Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer
dexamethasone
+ gemcitabine hydrochloride
+ paclitaxel
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: May 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesOpen USC/Norris Comprehensive Cancer Center and Hospital in Google Maps