A Phase II Trial of Paclitaxel Administered Weekly in Patients With Advanced Ovarian Cancer
paclitaxel
Urogenital Diseases+16
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: January 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: I. Evaluate the activity of paclitaxel when administered on a weekly schedule to patients with advanced ovarian cancer who have failed paclitaxel on a 3 or 24 hour infusion schedule. II. Evaluate the toxic effects of paclitaxel when administered on a weekly schedule in this patient population. III. Correlate response with quality of life outcomes, including symptom distress, performance status, and global quality of life. OUTLINE: This is a single center, open label study. Paclitaxel is administered intravenously every week as a 1 hour infusion. Patients receive prophylactic anti-allergy premedication prior to paclitaxel. PROJECTED ACCRUAL: 25-30 patients accrued per year.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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 or progressive epithelial ovarian cancer defined as: A serial rise in CA 125 over a minimum of 3 samples to a level greater than 50% of the upper limit of normal OR Measurable or evaluable disease Disease progression following paclitaxel given by 3 or 24 hour infusion within the past 6 months PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky at least 60% Life expectancy: Not specified Hematopoietic: AGC at least 1500/uL Platelet count at least 100,000/uL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: No active or uncontrolled infections No history of grade 3-4 peripheral neuropathy of any etiology No previously developed severe hypersensitivity reactions to paclitaxel Not pregnant or lactating Patients of childbearing potential must use effective method of contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior platinum based chemotherapy required Complete recovery from the myelosuppressive effects of prior chemotherapy for a minimum of 3 weeks At least one prior regimen of paclitaxel by 3 or 24 hour infusion within 6 months prior to study, with no intervening chemotherapy Endocrine therapy: No hormone therapy within 3 weeks of entry onto protocol Radiotherapy: No prior radiation therapy to major bone marrow ares within 4 weeks of entry onto protocol Surgery: Not specified
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps