Ovarian Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Los Angeles California, 90033, United States
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