Recruiting
Phase 2

Capecitabine, Panitumumab, Radiation Therapy

Sponsor:

Loma Linda Oncology Medical Group, Inc.

Code:

NCT00967655

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

panitumumab

capecitabine

irinotecan hydrochloride

neoadjuvant therapy

therapeutic conventional surgery

Study Details

Brief summary:

RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy, monoclonal antibody therapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying the side effects of giving capecitabine and panitumumab together with radiation therapy with or without irinotecan hydrochloride and to see how well it works in treating patients undergoing surgery for localized rectal cancer.

Conditions

Colorectal Cancer

Study ID

NCT00967655

Start date

Jul, 2009

Status verified date

Sep, 2009

Primary completion date

Jul, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the distal rectum (0-9 cm from the dentate line or 3-12 cm from the anal verge)
  • T3 or T4 tumor or nodal involvement by endorectal ultrasound or CT scan or MRI

  • Patients with any T status where tumor is close to but not involving the sphincter who otherwise would be candidates for abdominoperineal resection are eligible
  • No known homozygotes to UGT1A1\* 28
  • No distant metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 3 times ULN
  • Serum creatinine ≤ 1.5 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • Magnesium normal
  • Able to tolerate major surgery
  • Able and willing to comply with study requirements
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 weeks (males) or 24 weeks (females) after completion of study therapy
  • No prior diagnosis of interstitial lung disease
  • No prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
  • No other prior or concurrent invasive malignancy unless disease-free for ≥ 5 years
  • No lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets, or malabsorption syndrome
  • No concurrent serious infections
  • No clinically significant cardiovascular disease within the past year, including any of the following:

  • Myocardial infarction
  • Unstable angina
  • Symptomatic congestive heart failure
  • Symptomatic coronary artery disease
  • Serious uncontrolled cardiac arrhythmia
  • No history of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase risks associated with study participation or investigational product(s) administration or may interfere with the interpretation of the study results
  • No known positivity for HIV, hepatitis C, or acute or chronic active hepatitis B

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for rectal cancer
  • No prior anti-EGFr antibody therapy (e.g., cetuximab)
  • No prior treatment with small molecule EGFr inhibitors (e.g., gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)
  • No prior therapeutic radiotherapy to the pelvis
  • More than 28 days since prior major surgery
  • More than 14 days since prior minor surgery
  • At least 30 days since prior investigational agent or therapy
  • At least 4 weeks since prior and no concurrent sorivudine or brivudine
  • No concurrent chronic immunosuppressive agents (e.g., methotrexate or cyclosporine)
  • No concurrent cimetidine

Study Design

Enrollment

54 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

panitumumab

capecitabine

irinotecan hydrochloride

neoadjuvant therapy

therapeutic conventional surgery

radiation therapy

Primary outcome measure

  • Pathological complete response rate [ Time Frame: undefined ]
  • Grade 3/4 toxicity rate [ Time Frame: undefined ]
  • Disease-free survival [ Time Frame: undefined ]
  • Time to treatment failure [ Time Frame: undefined ]
  • 1-year survival rate [ Time Frame: undefined ]
  • 2-year survival rate [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Davood Vafai, MD, Medical Offices, Incorporated

Recruiting

Redlands, California, United States, 92374

Contacts

Pedro Bernal, MD

909-796-4333

Loma Linda Oncology Medical Group, Incorporated

Recruiting

Redlands, California, United States, 92374

Contacts

Pedro Bernal, MD

909-796-4333

New Hope Cancer and Research Institute - Glendora

Recruiting

Redlands, California, United States, 92374

Contacts

Pedro Bernal, MD

909-796-4333

New Hope Cancer and Research Institute - Pomona

Recruiting

Redlands, California, United States, 92374

Contacts

Pedro Bernal, MD

909-796-4333

More Information

Sponsor

Loma Linda Oncology Medical Group, Inc.

Last update posted

Jan 10, 2014

Last verified

Sep, 2009

Keywords

  • adenocarcinoma of the rectum
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loma Linda Oncology Medical Group, Inc. on 2014-01-10.