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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000065361 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-G97-1139 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Carol Aghajanian, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |