Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Evaluate the response rate, duration of response, and progression-free and overall survival of previously untreated patients with suboptimally debulked stage III or stage IV ovarian carcinoma, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma treated with docetaxel and carboplatin.
- Evaluate the feasibility and toxicity of this regimen in these patients.
- Evaluate the effect of this regimen on quality of life of these patients.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy.
PROJECTED ACCRUAL: Approximately 14-40 patients will be accrued for this study within 2.5 years.
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
-
-
New York
-
New York、New York、アメリカ、10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
-
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 previously untreated ovarian cancer, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma
- Suboptimally debulked stage III or suboptimally or optimally debulked stage IV
Measurable or evaluable disease
- CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented progression after radiotherapy) are not considered measurable
- CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross ascites are considered evaluable
- Ineligible for other high-priority national or institutional study
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-1
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT and/or SGPT less than 2.5 times ULN OR
- SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
- Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN
- No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than 2.5 times ULN
- Alkaline phosphatase less than 350 U/L
Renal:
- BUN less than 1.5 times normal
- Creatinine less than 1.5 times ULN
Other:
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer
- No other serious medical or psychiatric illness
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormone therapy
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy
Surgery:
- See Disease Characteristics
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
- マスキング：なし（オープンラベル）
協力者と研究者
捜査官
- スタディチェア：Amy D. Tiersten, MD、Herbert Irving Comprehensive Cancer Center
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
- CDR0000066624
- CPMC-IRB-8437
- NCI-V98-1467
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。