Spots Global Cancer Trial Database for Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer or Primary Peritoneal Cancer

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of amifostine, carboplatin and cyclophosphamide, followed by peripheral stem cell transplantation, in treating patients with epithelial ovarian cancer or primary peritoneal cancer.

Detailed Description: OBJECTIVES: I. Determine the maximum tolerated dose of high dose carboplatin with a fixed dose of high dose cyclophosphamide with amifostine pretreatment, and peripheral blood stem cell rescue in patients with ovarian epithelial cancer. II. Monitor engraftment kinetics such as granulocyte and platelet recovery. III. Determine the toxic effects of this regimen in this patient population. IV. Document the response of this patient population to this regimen in terms of time to progression, event free survival, and overall survival. OUTLINE: This is a dose escalation study. Patients undergo apheresis over 2-4 days to mobilize peripheral blood stem cells (PBSC). They then receive amifostine IV over 15 minutes. Fifteen minutes later, carboplatin is administered over 30 minutes on days -6 through -3. Cyclophosphamide IV is administered 1 hour after the carboplatin infusion is completed on days -6 through -4. PBSC are infused on day 0. Filgrastim (G-CSF) is administered beginning on day 4. Cohorts of 3-6 patients are treated at each dose level. At least 15 days must pass between the day of PBSC infusion and the next dose escalation. The dose limiting toxicity (DLT) is defined as the dose producing grade 3 or 4 nonhematologic toxicity in 2 of 6 patients. The maximum tolerated dose (MTD) is defined as one dose level below the DLT dose. At least 6 patients are treated at the MTD. Patients are followed monthly for 6 months, every 2-3 months for 1 year, and annually until death. PROJECTED ACCRUAL: This study will accrue 28 patients over 2 years.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

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