Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary, Fallopian Tube or Peritoneum
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving docetaxel together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or peritoneal cavity cancer treated with docetaxel and capecitabine.
Secondary
- Determine the time to progression in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life during treatment of these patients.
OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for ≥ 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, and then at completion of study treatment.
After completion of study treatment, patients are followed every 2-3 months.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
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
Inclusion Criteria:
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Ovarian epithelial adenocarcinoma
- Fallopian tube cancer
- Peritoneal cavity cancer
- Recurrent or persistent disease after no more than 2 prior treatment regimens (1 regimen for primary disease and/or 1 regimen for recurrent disease)
Platinum-resistant disease, defined as 1 of the following:
- Treatment-free interval < 6 months after platinum-based therapy
- Disease progression during platinum-based therapy
- Measurable disease by physical exam, chest x-ray, CT scan, or MRI
- No brain metastases
PATIENT CHARACTERISTICS:
- Gynecologic Oncology Group performance status 0-2
- Life expectancy > 6 months
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8 g/dL
- Creatinine clearance ≥ 50 mL/min
- Bilirubin normal
AST or ALT and alkaline phosphatase (AP) meeting 1 of the following criteria:
- AST or ALT ≤ 5 times upper limit of normal (ULN) AND AP normal
- AST or ALT ≤ 1.5 times ULN AND AP ≤ 2.5 times ULN
- AST or ALT normal AND AP ≤ 5 times ULN
- No peripheral neuropathy > grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No other concurrent malignancy except for curatively treated nonmelanoma skin cancer
- No prior invasive malignancy < 5 years after curative therapy
- No serious uncontrolled medical or psychiatric illness that would preclude study participation or limit survival to < 6 months
- No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 or to fluoropyrimidine therapy or fluorouracil
- No inability to tolerate oral medication due to bowel obstruction, lack of physical integrity of the upper gastrointestinal tract, inability to swallow, or malabsorption syndrome
- No serious concurrent infections
No clinically significant cardiac disease not well controlled with medication, including any of the following:
- Congestive heart failure
- Symptomatic coronary artery disease
- Symptomatic cardiac arrhythmias
- Myocardial infarction within the past 12 months
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior docetaxel or capecitabine or other fluoropyrimidine therapy
- Recovered from prior therapy
- At least 2 weeks since prior major surgery
- At least 4 weeks since prior chemotherapy, hormone therapy, or radiotherapy
- No other concurrent chemotherapeutic agents, biological therapy, radiotherapy, or other investigational agents
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
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Weekly Docetaxel and Capecitabine
|
oral capecitabine twice daily on days 1-21
docetaxel IV over 30 minutes on days 1, 8, and 15
|
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 |
メジャーの説明 |
時間枠 |
---|---|---|
Objective Tumor Response
時間枠:8 weeks
|
The number of partial and complete responders among all evaluable patients as defined using Response Evaluation Criteria in Solid Tumors guidelines
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time to Progression
時間枠:Evaluated every 8 weeks during treatment
|
Progression is defined as a 20% increase in tumor size of all the target lesions along the longest diameter
|
Evaluated every 8 weeks during treatment
|
Number of Participants With Grade 3 or Higher Toxicity
時間枠:Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
|
summary of grade 3 (per Common Toxicity Criteria) or higher toxicities which generally is described as a severe adverse reaction or symptom.
|
Days 1, 8, 15, 21 of each course and treatment end (28 days after last dose or start of new therapy)
|
Quality of Life
時間枠:Pre-entry, day 1, treatment end
|
comparison of treatment end to pre entry and day 1 of each treatment cycle.
|
Pre-entry, day 1, treatment end
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (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 (実際)
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
- CCCWFU-83203
- CCCWFU-BG05-536
- AVENTIS-CCCWFU-83203
- CDR0000489036
- ROCHE-CCCWFU-BG05-536
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
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