Spots Global Cancer Trial Database for Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

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Trial Identification

Brief Title: Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

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

Study ID: NCT00003160

Conditions

Fallopian Tube Cancer

Ovarian Cancer

Primary Peritoneal Cavity Cancer

Interventions

paclitaxel

Study Description

Brief Summary: 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.

Detailed Description: 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.