Ovarian Cancer Clinical Trial
Official title:
A Phase I/II Dose Escalation Trial of Carboplatin With Amifostine Pretreatment to Augment High Dose Cyclophosphamide With Autologous Peripheral Blood Stem Cell Support for the Treatment of Patients With Epithelial Ovarian Cancer
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.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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