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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002928 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or progressive advanced epithelial ovarian cancer following previous paclitaxel.
Condition | Intervention | Phase |
Ovarian Cancer |
Drug: paclitaxel |
Phase II |
MedlinePlus related topics: | Cancer Ovarian Cancer |
ChemIDplus related topics: | Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Paclitaxel Administered Weekly in Patients With Advanced Ovarian Cancer |
Study Start Date: | January 1997 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Carol Aghajanian, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065361, MSKCC-96070, NCI-G97-1139 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002928 |
Health Authority: | United States: Federal Government |
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