Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.

Detailed Description
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OBJECTIVES: Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine. Determine the toxic effects of this regimen in these patients. Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients. OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel). Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed until death. PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study.

Official Title
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Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: dexamethasone
* Drug: gemcitabine hydrochloride
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial cancer Platinum resistant disease defined as: Progression during the most recent platinum-based chemotherapy OR Relapse less than 6 months after platinum-based chemotherapy Measurable or evaluable disease Elevated CA-125 only allowed Positive cytology only not eligible PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 3 times ULN Renal: Creatinine no greater than 2 mg/dL Neurologic: No peripheral neuropathy greater than grade 2 Other: No other serious medical illness or psychiatric conditions. PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics No prior gemcitabine No prior paclitaxel administered weekly Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from acute toxic effects secondary to prior therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone|nan|
|Drug: gemcitabine hydrochloride|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer