Expired Study
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Los Angeles, California 90033


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003449


Primary Contact:

Study Chair
Agustin Garcia, MD
University of Southern California


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 16, 2017

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