Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.
調査の概要
詳細な説明
OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival in these patients. IV. Assess quality of life in these patients.
OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks. Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience. Patients receive paclitaxel weekly until disease progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study. Quality of life is assessed every cycle for the first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: There will be 100 patients accrued into this study.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Alabama
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Mobile、Alabama、アメリカ、36608
- Oncology Center at Providence Park
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Arizona
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Phoenix、Arizona、アメリカ、85013
- Hematology Associates, Ltd.
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Arkansas
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Fayetteville、Arkansas、アメリカ、72703
- Highlands Oncology Group, P.A.
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California
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Santa Barbara、California、アメリカ、93105
- Cancer Center of Santa Barbara
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Florida
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West Palm Beach、Florida、アメリカ、33401
- Good Samaritan Medical Center
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Illinois
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Decatur、Illinois、アメリカ、62526
- Decatur Memorial Hospital Cancer Care Institute
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Nebraska
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Omaha、Nebraska、アメリカ、68131-2197
- Creighton University Cancer Center
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New Jersey
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Neptune、New Jersey、アメリカ、07753
- Jersey Shore Cancer Center
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New York
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Albany、New York、アメリカ、12209
- Women's Health Center at Albany Medical Center
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North Carolina
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Charlotte、North Carolina、アメリカ、28232-2861
- Carolinas Medical Center
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Ohio
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Akron、Ohio、アメリカ、44302
- Akron General Medical Center
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Cincinnati、Ohio、アメリカ、45219
- Oncology/Hematology Care, Inc.
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Cancer Center
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Pennsylvania
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Harrisburg、Pennsylvania、アメリカ、17105-8700
- Women's Cancer Center of Central PA, P.C.
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Rhode Island
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Providence、Rhode Island、アメリカ、02905
- Women and Infants Hospital of Rhode Island
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Tennessee
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Nashville、Tennessee、アメリカ、37203
- Brookview Research, Inc.
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Texas
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Amarillo、Texas、アメリカ、79106
- Harrington Cancer Center
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Washington
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Spokane、Washington、アメリカ、99202
- Rockwood Clinic P.S.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
協力者と研究者
スポンサー
捜査官
- スタディチェア：Maurie Markman, MD、The Cleveland Clinic
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000065955
- THERADEX-B97-3250
- BMS-TAX/MEN.03
- NCI-V97-1366
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