Recruiting
Phase 3

Cabazitaxel & Carboplatin

Sponsor:

SWOG Cancer Research Network

Code:

NCT06470243

Conditions

Castration-Resistant Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Bone Scan

Cabazitaxel

Carboplatin

Chest Radiography

Study Details

Brief summary:

This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.

Conditions

Castration-Resistant Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Study ID

NCT06470243

Start date

Nov 27, 2024

Status verified date

Jan, 2026

Completion date

Apr, 2034

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • STEP 1 SCREENING REGISTRATION: NOTE: All participants must have biopsy tissue submitted to MD Anderson Cancer Center prior to randomization for alteration assessment. Participants must have determination of their AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status from central assessment by the MD Anderson Clinical Pathology Laboratory using Clinical Laboratory Improvement Act (CLIA) certified immunohistochemistry (IHC) assays for TP53, RB1 and PTEN. In addition, while not mandated, CLIA certified next generation sequencing (NGS) of tumor deoxyribonucleic acid (DNA) and/or circulating tumor derived DNA (ctDNA) assessment of AVPC-MS marker status will be collected from participants for whom it is available
  • STEP 1 SCREENING REGISTRATION: Participants must have a histologically confirmed diagnosis of prostate cancer at the time of step 1 registration
  • STEP 1 SCREENING REGISTRATION: Participants must have castrate-resistant prostate cancer and metastatic disease by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node)
  • STEP 1 SCREENING REGISTRATION: Participants may have received any prior therapy, but one must be docetaxel or contain docetaxel in either the castrate-sensitive and/or castrate resistant disease state
  • STEP 1 SCREENING REGISTRATION: Participants must be ≥ 18 years of age at the time of step 1 screening registration
  • STEP 1 SCREENING REGISTRATION: Participants must have solid tumor biopsy material (formalin-fixed paraffin-embedded (FFPE) tissue blocks and/or 10 cut slides on four-micron thick unstained positive charged slides of FFPE tissue) available for submission for alterations in TP53, RB1 and PTEN by IHC using CLIA certified assays in the MD Anderson Clinical Pathology Laboratory. This specimen is required for central assessment of the AVPC-MSIHC regardless of whether the site has already locally evaluated the AVPC-MS status
  • STEP 1 SCREENING REGISTRATION: Tumor samples submitted for analysis must have been collected within 12 months prior to step 1 screening registration. Samples from metastatic lesions collected in the castrate-resistant disease state are preferable but not mandatory. Samples obtained during the hormone-naive disease state are acceptable if collected within 12 months of step 1 screening registration. If more than one tumor sample exists, the sample obtained closest to the date of registration should be submitted to MDACC for analysis

  • NOTE: Sites will receive an email from Southwest Oncology Group (SWOG) Statistics and Data Management Center containing participant results of Aggressive Variant Prostate Cancer Molecular Signature (AVPC-MS) assessment within 5-12 business days after tissue submission to MD Anderson Clinical Pathology Laboratory. The participant's AVPC-MS signature result (positive or negative) is required BEFORE randomization on to step 2. If sites receive a non-evaluable AVPC-MS signature result, SWOG Statistics and Data Management Center will provide instructions for resubmission
  • STEP 1 SCREENING REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • STEP 1 SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. Documentation of informed consent via remote consent is allowed

  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
  • STEP 2 RANDOMIZATION: NOTE: Participants must be registered to step 2 randomization within 70 days after registration to step 1. Participants must plan to start protocol therapy no more than 14 days after step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must have castrate levels of testosterone with a baseline level < 50ng/dL within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must have evidence for metastatic prostate cancer by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node). Visceral and/or soft-tissue metastases must be ≥ 1.0 cm in diameter and lymph nodes must be > 1.5 cm diameter in the short axis. Scans must be obtained within 28 days prior to randomization

  • NOTE: All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
  • STEP 2 RANDOMZIATION: Participants must have progressive disease (PD) in the opinion of the treating investigator according to any of the following criteria

  • Progression in measurable disease (RECIST 1.1 criteria). Patient with measurable disease must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) \[CT scan thickness no greater than 5 mm\] or magnetic resonance imaging (MRI). Lymph nodes should be ≥ 15 mm in short axis. Previously irradiated lesions, primary prostate lesion and bone lesions will be considered non-measurable disease
  • Progression in bone as evidenced by:

  • Appearance of 2 or more new bone lesions on bone scan (BS). If equivocal, they must be confirmed by other imaging modalities (CT; MRI), and/or repeat BS > 4 weeks later
  • Appearance of a new lytic lesion(s) and/or increasing size of an existing lesion by CT/MRI, since AVPC tumors may produce lytic bone lesions that are not detected on conventional bone scans
  • Rising prostate-specific antigen (PSA) defined (Prostate Cancer Working Group 2 \[PCWG2\]) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart. The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA measure is required to be taken and be greater than the 2nd measure. In case of progression based on rising PSA only, the first rising PSA (measure 2) must be obtained within 6 months of initiation of androgen receptor (AR) targeted therapy (≤ 6 months)
  • Clinical progression. Increasing symptoms unequivocally attributed to disease progression as judged by the treating physician
  • STEP 2 RANDOMIZATION: Participants must not have received prior cabazitaxel or carboplatin
  • STEP 2 RANDOMIZATION: Participants must not be receiving treatment on another therapeutic clinical trial at the time of randomization. Chemotherapies, bone targeting therapies, immunotherapies and clinical trial agents must be discontinued ≥ 21 days prior to randomization. Stereotactic radiation (SART) must be discontinued ≥ 3 days prior to randomization
  • STEP 2 RANDOMIZATION: Participants must not be receiving radiation therapy or kyphoplasty-vertebroplasty within 14 days prior to randomization or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must not have untreated fractures and/or cord compression
  • STEP 2 RANDOMIZATION: Participants must not have symptomatic uncontrolled brain metastases. Properly treated brain metastases (i.e., with stereotactic radiation) within 14 days are allowed
  • STEP 2 RANDOMIZATION: Participants must have Zubrod performance status of 0 - 2 within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants must have a complete medical history and physical exam within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Platelets ≥ 100 x 10\^3/uL (unless clinical evidence of bone marrow infiltration by tumor in which case > 75 x 10\^3/uL are allowed) (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome or if the participant has liver metastases and/or acute tumor associated illness < 4x ULN (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (or if participant has liver metastases and/or acute tumor-associated illness, ≤ 4x institutional ULN) (within 28 days prior to step 2 randomization)
  • STEP 2 REGISTRATION: Participants must have a calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 randomization
  • STEP 2 RANDOMIZATION: Participants with peripheral neuropathy must have ≤ grade 2 peripheral neuropathy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) (within 28 days prior to step 2 randomization)
  • STEP 2 RANDOMIZATION: Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen
  • STEP 2 RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen
  • STEP 2 RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
  • STEP 2 RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System

Study Design

Enrollment

528 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1 (cabazitaxel, prednisone)

Patients receive cabazitaxel IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.

experimental: Arm 2 (cabazitaxel, carboplatin, prednisone)

Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.

Interventions

Biospecimen Collection

Undergo blood sample collection

Bone Scan

Undergo bone scan

Cabazitaxel

Given IV

Carboplatin

Given IV

Chest Radiography

Undergo chest x-ray

Computed Tomography

Undergo CT or PET/CT

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET/CT

Prednisone

Given PO

Primary outcome measure

  • Radiographic progression-free survival (rPFS) [ Time Frame: From date of randomization to the first documentation of rPFS event, assessed up to 5 years ]

Central Contacts and Locations

Locations

Highlands Oncology Group - Fayetteville

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group - Rogers

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Principal Investigator:

Joseph T. Beck

Tibor Rubin VA Medical Center

Recruiting

Long Beach, California, United States, 90822

Contacts

Site Public Contact

562-826-8000

Principal Investigator:

Pankaj Gupta

Beebe Medical Center

Recruiting

Lewes, Delaware, United States, 19958

Contacts

Principal Investigator:

Gregory A. Masters

Beebe South Coastal Health Campus

Recruiting

Millville, Delaware, United States, 19967

Contacts

Principal Investigator:

Gregory A. Masters

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Christiana Care Health System-Christiana Hospital

Recruiting

Newark, Delaware, United States, 19718

Contacts

Principal Investigator:

Gregory A. Masters

Beebe Health Campus

Recruiting

Rehoboth Beach, Delaware, United States, 19971

Contacts

Principal Investigator:

Gregory A. Masters

Christiana Care Health System-Wilmington Hospital

Recruiting

Wilmington, Delaware, United States, 19801

Contacts

Principal Investigator:

Gregory A. Masters

Holy Cross Hospital

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Site Public Contact

eileen.georgi@holy-cross.com

Principal Investigator:

Elie G. Dib

Saint Alphonsus Cancer Care Center-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Principal Investigator:

John M. Schallenkamp

Saint Alphonsus Cancer Care Center-Caldwell

Recruiting

Caldwell, Idaho, United States, 83605

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Idaho Urologic Institute-Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Principal Investigator:

John M. Schallenkamp

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Principal Investigator:

John M. Schallenkamp

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Principal Investigator:

Bryan A. Faller

Memorial Hospital of Carbondale

Recruiting

Carbondale, Illinois, United States, 62902

Contacts

Principal Investigator:

Bryan A. Faller

SIH Cancer Institute

Recruiting

Carterville, Illinois, United States, 62918

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Principal Investigator:

Bryan A. Faller

Centralia Oncology Clinic

Recruiting

Centralia, Illinois, United States, 62801

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Maha H. Hussain

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Natalie Reizine

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Maha H. Hussain

Illinois CancerCare-Dixon

Recruiting

Dixon, Illinois, United States, 61021

Contacts

Site Public Contact

815-285-7800

Principal Investigator:

Bryan A. Faller

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Principal Investigator:

Bryan A. Faller

Western Illinois Cancer Treatment Center

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Site Public Contact

309-344-2831

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Maha H. Hussain

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Maha H. Hussain

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Maha H. Hussain

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Maha H. Hussain

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Maha H. Hussain

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

Methodist Medical Center of Illinois

Recruiting

Peoria, Illinois, United States, 61636

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Principal Investigator:

Bryan A. Faller

Valley Radiation Oncology

Recruiting

Peru, Illinois, United States, 61354

Contacts

Site Public Contact

815-664-4141

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Principal Investigator:

Bryan A. Faller

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Memorial Medical Center

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Maha H. Hussain

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Principal Investigator:

Bryan A. Faller

Reid Health

Recruiting

Richmond, Indiana, United States, 47374

Contacts

Principal Investigator:

Howard M. Gross

Mercy Hospital

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-365-4673

Principal Investigator:

Deborah W. Wilbur

Oncology Associates at Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-363-2690

Principal Investigator:

Deborah W. Wilbur

Christiana Care - Union Hospital

Recruiting

Elkton, Maryland, United States, 21921

Contacts

Principal Investigator:

Gregory A. Masters

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Elie G. Dib

Caro Cancer Center

Recruiting

Caro, Michigan, United States, 48723

Contacts

Principal Investigator:

Elie G. Dib

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Elie G. Dib

Hematology Oncology Consultants-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Principal Investigator:

Elie G. Dib

Newland Medical Associates-Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Health Saint John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

Great Lakes Cancer Management Specialists-Doctors Park

Recruiting

East China Township, Michigan, United States, 48054

Contacts

Principal Investigator:

Elie G. Dib

Genesee Cancer and Blood Disease Treatment Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Elie G. Dib

Genesee Hematology Oncology PC

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Elie G. Dib

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Elie G. Dib

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Principal Investigator:

Elie G. Dib

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Academic

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Breast

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Elie G. Dib

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Warren Hospital - Breast Macomb

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Principal Investigator:

Elie G. Dib

Saint Mary's Oncology/Hematology Associates of Marlette

Recruiting

Marlette, Michigan, United States, 48453

Contacts

Principal Investigator:

Elie G. Dib

Hope Cancer Center

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Elie G. Dib

Michigan Healthcare Professionals Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Elie G. Dib

Newland Medical Associates-Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Elie G. Dib

MyMichigan Medical Center Saginaw

Recruiting

Saginaw, Michigan, United States, 48601

Contacts

Principal Investigator:

Elie G. Dib

Oncology Hematology Associates of Saginaw Valley PC

Recruiting

Saginaw, Michigan, United States, 48604

Contacts

Principal Investigator:

Elie G. Dib

MyMichigan Medical Center Tawas

Recruiting

Tawas City, Michigan, United States, 48764

Contacts

Principal Investigator:

Elie G. Dib

Great Lakes Cancer Management Specialists-Macomb Professional Building

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Madison Heights Hospital - Breast

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Elie G. Dib

Saint John Macomb-Oakland Hospital

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Elie G. Dib

Saint Mary's Oncology/Hematology Associates of West Branch

Recruiting

West Branch, Michigan, United States, 48661

Contacts

Principal Investigator:

Elie G. Dib

Huron Gastroenterology PC

Recruiting

Ypsilanti, Michigan, United States, 48106

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Elie G. Dib

Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, United States, 55337

Contacts

Principal Investigator:

David M. King

Cambridge Medical Center

Recruiting

Cambridge, Minnesota, United States, 55008

Contacts

Principal Investigator:

David M. King

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

David M. King

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

David M. King

Fairview Clinics and Surgery Center Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

David M. King

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

David M. King

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

David M. King

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Principal Investigator:

David M. King

Health Partners Inc

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Principal Investigator:

David M. King

Monticello Cancer Center

Recruiting

Monticello, Minnesota, United States, 55362

Contacts

Principal Investigator:

David M. King

New Ulm Medical Center

Recruiting

New Ulm, Minnesota, United States, 56073

Contacts

Principal Investigator:

David M. King

Fairview Northland Medical Center

Recruiting

Princeton, Minnesota, United States, 55371

Contacts

Principal Investigator:

David M. King

North Memorial Medical Health Center

Recruiting

Robbinsdale, Minnesota, United States, 55422

Contacts

Principal Investigator:

David M. King

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

David M. King

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

David M. King

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

David M. King

Saint Francis Regional Medical Center

Recruiting

Shakopee, Minnesota, United States, 55379

Contacts

Principal Investigator:

David M. King

Lakeview Hospital

Recruiting

Stillwater, Minnesota, United States, 55082

Contacts

Principal Investigator:

David M. King

Ridgeview Medical Center

Recruiting

Waconia, Minnesota, United States, 55387

Contacts

Principal Investigator:

David M. King

Rice Memorial Hospital

Recruiting

Willmar, Minnesota, United States, 56201

Contacts

Principal Investigator:

David M. King

Minnesota Oncology Hematology PA-Woodbury

Recruiting

Woodbury, Minnesota, United States, 55125

Contacts

Principal Investigator:

David M. King

Fairview Lakes Medical Center

Recruiting

Wyoming, Minnesota, United States, 55092

Contacts

Principal Investigator:

David M. King

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

John C. Henegan

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Southeast Cancer Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-651-5550

Principal Investigator:

Bryan A. Faller

Parkland Health Center - Farmington

Recruiting

Farmington, Missouri, United States, 63640

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Sainte Genevieve County Memorial Hospital

Recruiting

Sainte Genevieve, Missouri, United States, 63670

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Missouri Baptist Sullivan Hospital

Recruiting

Sullivan, Missouri, United States, 63080

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

BJC Outpatient Center at Sunset Hills

Recruiting

Sunset Hills, Missouri, United States, 63127

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Great Falls Clinic

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Kalispell Regional Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

Nebraska Medicine-Bellevue

Recruiting

Bellevue, Nebraska, United States, 68123

Contacts

Principal Investigator:

Benjamin A. Teply

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Benjamin A. Teply

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Benjamin A. Teply

Indu and Raj Soin Medical Center

Recruiting

Beavercreek, Ohio, United States, 45431

Contacts

Principal Investigator:

Howard M. Gross

Saint Elizabeth Boardman Hospital

Recruiting

Boardman, Ohio, United States, 44512

Contacts

Principal Investigator:

Howard M. Gross

Dayton Physicians LLC-Miami Valley South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Principal Investigator:

Howard M. Gross

Oncology Hematology Care Inc-Kenwood

Recruiting

Cincinnati, Ohio, United States, 45236

Contacts

Principal Investigator:

Howard M. Gross

Dayton Physician LLC - Englewood

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Principal Investigator:

Howard M. Gross

Armes Family Cancer Center

Recruiting

Findlay, Ohio, United States, 45840

Contacts

Principal Investigator:

Howard M. Gross

Blanchard Valley Hospital

Recruiting

Findlay, Ohio, United States, 45840

Contacts

Principal Investigator:

Howard M. Gross

Orion Cancer Care

Recruiting

Findlay, Ohio, United States, 45840

Contacts

Principal Investigator:

Howard M. Gross

Dayton Physicians LLC-Atrium

Recruiting

Franklin, Ohio, United States, 45005

Contacts

Principal Investigator:

Howard M. Gross

Dayton Physicians LLC-Wayne

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Principal Investigator:

Howard M. Gross

Wayne Hospital

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Principal Investigator:

Howard M. Gross

Greater Dayton Cancer Center

Recruiting

Kettering, Ohio, United States, 45409

Contacts

Principal Investigator:

Howard M. Gross

Kettering Medical Center

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Principal Investigator:

Howard M. Gross

Dayton Physicians LLC - Troy

Recruiting

Troy, Ohio, United States, 45373

Contacts

Principal Investigator:

Howard M. Gross

Saint Joseph Warren Hospital

Recruiting

Warren, Ohio, United States, 44484

Contacts

Principal Investigator:

Howard M. Gross

Saint Elizabeth Youngstown Hospital

Recruiting

Youngstown, Ohio, United States, 44501

Contacts

Principal Investigator:

Howard M. Gross

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Adanma Anji Ayanambakkam Attanathi

Saint Alphonsus Cancer Care Center-Baker City

Recruiting

Baker City, Oregon, United States, 97814

Contacts

Principal Investigator:

John M. Schallenkamp

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Principal Investigator:

John M. Schallenkamp

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Principal Investigator:

Elie G. Dib

Lehigh Valley Hospital - Muhlenberg

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Contacts

Principal Investigator:

Elie G. Dib

Christiana Care Health System-Concord Health Center

Recruiting

Chadds Ford, Pennsylvania, United States, 19317

Contacts

Principal Investigator:

Gregory A. Masters

Pocono Medical Center

Recruiting

East Stroudsburg, Pennsylvania, United States, 18301

Contacts

Principal Investigator:

Elie G. Dib

Lehigh Valley Hospital-Hazleton

Recruiting

Hazleton, Pennsylvania, United States, 18201

Contacts

Principal Investigator:

Elie G. Dib

The West Clinic - Wolf River

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Principal Investigator:

Bradley G. Somer

MD Anderson in The Woodlands

Recruiting

Conroe, Texas, United States, 77384

Contacts

Principal Investigator:

Paul Corn

Lyndon Baines Johnson General Hospital

Recruiting

Houston, Texas, United States, 77026-1967

Contacts

Site Public Contact

713-566-5000

Principal Investigator:

Paul Corn

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Paul Corn

MD Anderson West Houston

Recruiting

Houston, Texas, United States, 77079

Contacts

Principal Investigator:

Paul Corn

MD Anderson League City

Recruiting

League City, Texas, United States, 77573

Contacts

Principal Investigator:

Paul Corn

MD Anderson in Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Principal Investigator:

Paul Corn

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

John Melson

Virginia Commonwealth University/Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

CTOclinops@vcu.edu

Principal Investigator:

John Melson

Cancer Center of Western Wisconsin

Recruiting

New Richmond, Wisconsin, United States, 54017

Contacts

Principal Investigator:

David M. King

Billings Clinic-Cody

Recruiting

Cody, Wyoming, United States, 82414

Contacts

Principal Investigator:

John M. Schallenkamp

Welch Cancer Center

Recruiting

Sheridan, Wyoming, United States, 82801

Contacts

Principal Investigator:

John M. Schallenkamp

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-01-22.