Recruiting
Phase 2

Hyperthermic Chemotherapy

Sponsor:

Bay Area Gynecology Oncology

Code:

NCT02349958

Conditions

Ovarian Cancer

Peritoneal Cancer

Fallopian Tube Cancer

Uterine Cancer

Mesotheliomas

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

HIPEC: MMC 30mg @ T0, 10mg @ T45min

HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0

HIPEC: CDDP 75 mg/m2 @T0

HIPEC: CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0

Study Details

Brief summary:

To determine treatment response to surgical debulking and intra-operative Intraperitoneal Hyperthermic Chemotherapy (IPHC) in patients with the following malignancies:

Gynecologic cancers (ovarian, primary peritoneal or fallopian tube, and uterine/cervical cancers).

Mesotheliomas. GI cancers (Gallbladder, liver, small intestine, pancreas, stomach, colon, appendix).

To monitor the toxicities and complications of this treatment regimen. To measure treatment related QOL changes after IPHC.

Conditions

Ovarian Cancer

Peritoneal Cancer

Fallopian Tube Cancer

Uterine Cancer

Mesotheliomas

Study ID

NCT02349958

Start date

Sep, 2006

Status verified date

Apr, 2019

Completion date

Jan, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

PATIENT ELIGIBILITY

Presumptive clinical diagnosis of a peritoneal surface cancer (PSC) prior to surgery, with no metastases outside of the abdomen.

Patients must have a performance status of 0, 1, or 2.

Patients must have adequate:

Bone marrow function: absolute neutrophil count more than or equal to 1500 and platelet count more than or equal to 100,000 Renal function: creatinine less than or equal to 1.5 mg/dl Hepatic function: bilirubin less than or equal 1.5times upper limit of normal, SGOT and alkaline phosphatase less than or equal 2.5 times upper limit of normal range Patients must have signed an informed consent. Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception.

Patients are at least 18 years of age, and under 75 years of age.

At the time of surgery, operative assessment and frozen section diagnosis of one of the following:

Primary ovarian cancer (POC) with Stage IC or greater stage Recurrent or persistent ovarian cancer (ROC) Ovarian cancer patients who desire Consolidation Chemotherapy (CC). These patients would ordinarily choose to have 12 cycles of Taxol given after standard first-line surgery and chemotherapy, and instead choose one course of IPHC as their CC.

Uterine malignancy of the corpus, or cervix with primary tumor Stage IIIA or greater, or recurrent tumor confined to the abdomen.

Metastatic mesothelioma or sarcoma confined to the abdomen. Recurrent or primary gastrointestinal cancer, with regional spread confined to the peritoneal cavity

PATIENT INELIGIBILITY

Patients with known extra-abdominal disease, or unresected bulky abdominal retroperitoneal lymph nodes.

Patients with any evidence of another malignancy within the last five years (except non-melanoma skin cancer) Patients with a known sensitivity to cisplatin, Mitomycin C, or Adriamycin. Patients with significant co-morbid medical conditions that would prevent the patient from completing treatment on this protocol, per Investigator discretion.

Patients desiring future fertility.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Ovarian peritoneal

CDDP Cisplatin 75 mg/m2 @T0 Ovarian peritoneal fallopian tube Uterine

other: Appendix Psuedomyxoma

MMC Mitomycin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0 Appendix Psuedomyxoma colorectal small bowel

other: Gastric and Pancreato-biliary

MMC Mitomycin + CDDP Cisplatin 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0

other: Mesothelioma and Sarcoma

CDDP Cisplatin + Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0

Interventions

HIPEC: MMC 30mg @ T0, 10mg @ T45min

MMC 30mg @ T0, 10mg @ T45min for Appendix, Psuedomyxoma, colorectal, small bowel

HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0

Gastric and Pancreato-biliary HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min

HIPEC: CDDP 75 mg/m2 @T0

Ovarian/peritoneal/fallopian tube, Uterine CDDP 75 mg/m2 @T0

HIPEC: CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0

CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0 Mesothelioma and Sarcoma

Primary outcome measure

  • measure treatment response to HIPEC and tumor debulking [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

James Lilja

Recruiting

Los Gatos, California, United States, 95032

Contacts

Principal Investigator:

James Lilja, MD

More Information

Sponsor

Bay Area Gynecology Oncology

Last update posted

Apr 16, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bay Area Gynecology Oncology on 2019-04-16.