Ovarian Cancer Clinical Trial
Official title:
A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with
stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based
regimens.
OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one
hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian
cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the
overall survival in these patients. IV. Assess quality of life in these patients.
OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered
paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks.
Treatment may be delayed for up to 2 weeks and there is no limit to the number of
interruptions a patient may experience. Patients receive paclitaxel weekly until disease
progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and
then every 6 months thereafter during study. Quality of life is assessed every cycle for the
first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for
survival.
PROJECTED ACCRUAL: There will be 100 patients accrued into this study.
;
Primary Purpose: Treatment
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