Overview

Paclitaxel in Treating Patients With Recurrent or Progressive Advanced Ovarian Cancer

Status:
Completed
Trial end date:
2001-08-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
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