Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
- Determine the response rates (complete and partial response) in patients treated with this regimen.
- Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington School of Medicine
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Seattle、Washington、アメリカ、98104
- Pacific Gynecology Specialists
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Seattle、Washington、アメリカ、98109-1024
- Fred Hutchinson Cancer Research Center
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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 ovarian epithelial or primary peritoneal cavity cancer
- Stage III or IV disease
- No borderline tumors
Measurable or evaluable disease
- Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
- Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
In first relapse
- Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Platelet count ≥ 100,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
- SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal
Renal
- Creatinine ≤ 2.0 mg/dL
- Creatinine clearance > 50 mL/min
Cardiovascular
- LVEF ≥ 50%
- No poorly controlled arrhythmia
- No unstable coronary artery disease or myocardial infarction within the past year
Other
- HIV negative
- No pre-existing peripheral neuropathy > grade 2
- No history of allergy to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy and recovered
Surgery
- Recovered from recent prior surgery
Other
- No concurrent myelosuppressive therapy
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)
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
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毒性
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全生存
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イベントフリーサバイバル
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再発率
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Response rates (complete and partial response)
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協力者と研究者
捜査官
- 主任研究者:Leona A. Holmberg, MD, PhD、Fred Hutchinson Cancer Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
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
- PSOC 1702
- PSOC-1702
- AVENTIS-PSOC-1702
- PSOC-IRB-4861
- CDR0000441307 (レジストリ識別子:PDQ)
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。