Ovarian Cancer Clinical Trial
Official title:
A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Suboptimally Debulked Stage III or IV Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
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 II trial to study the effectiveness of combination chemotherapy plus
peripheral stem cell transplantation in treating patients who have stage III or stage IV
ovarian, fallopian tube, or primary peritoneal cancer.
OBJECTIVES: I. Determine pathological complete response rate in patients with suboptimally
debulked stage III or stage IV ovarian, fallopian tube, or primary peritoneal carcinoma
treated with sequential paclitaxel, carboplatin, and topotecan with peripheral blood stem
cell rescue. II. Determine disease free and overall survival of these patients.
OUTLINE: Patients receive mobilization with cyclophosphamide IV over 1 hour, followed 4
hours later by paclitaxel IV over 24 hours. Filgrastim (G-CSF) is administered
subcutaneously beginning 24 hours after completion of paclitaxel and continues through stem
cell harvest. Peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells.
High dose sequential chemotherapy begins 21 days after leukapheresis. Patients receive
paclitaxel IV over 24 hours on day 1, carboplatin IV over 2 hours on day 2, and then
topotecan IV over 24 hours. G-CSF is administered subcutaneously beginning on day 3 until
blood counts recover. PBSC are reinfused on day 4. Treatment repeats every 28 days for up to
4 courses in the absence of disease progression or unacceptable toxicity. Patients with
radiographic and biochemical complete response undergo second look surgery within 8 weeks of
completing the last course of chemotherapy.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
;
Primary Purpose: Treatment
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