A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
調査の概要
詳細な説明
Combination chemotherapy has advantages over monochemotherapy due to the higher response rates that can often be obtained; by using agents with non-overlapping toxicity profiles, these responses can be achieved with less toxicity than maximally tolerated doses of single agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy is that both agents appear to have a toxicity profile appropriate for palliative therapy of advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a one-week rest to coincide with the 14-day schedule of capecitabine.
The primary objective is to evaluate the overall response rate (complete and partial responses) according to the RECIST criteria of the combination of capecitabine and docetaxel with the selected schedule in patients with advanced and/or metastatic breast cancer. The secondary objectives are to evaluate tolerability, time to tumor progression, and time to treatment failure of the combination of capecitabine and docetaxel.
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
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Florida
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Plantation、Florida、アメリカ、33324
- Cancer Research Network, Inc.
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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
Inclusion Criteria:
- Female patients with histopathologically proven metastatic breast cancer.
- Patients 18-75 years old
- Performance status: Karnofsky > 70%
- Patients must have measurable disease. Patients with only blastic bone lesions are ineligible.
- Adequate bone marrow, liver, renal and cardiac functions defined as:
- Ability to understand the study and give informed consent.
- Patients may not have received more than one prior chemotherapy for metastatic breast cancer. 5-FU or Taxol given as part of an adjuvant regimen will not render the patient ineligible.
Exclusion Criteria:
- Patients with brain metastasis, adequately treated and stable and not requiring continued steroid medication will be eligible if no progression for > 3 months.
- Patients who have received any anti-cancer investigational agent in the month prior to inclusion.
- Patients previously treated with docetaxel(Taxotere)or capecitabine (Xeloda).
- Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome.
- Patients with renal impairment (creatinine clearance below 30 ml/min calculated according to Cockcroft and Gault, see Appendix D), since capecitabine is contraindicated in patients with severe renal impairment.
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：非ランダム化
- 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）
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 |
時間枠 |
|---|---|
|
To find the lowest tolerable efficacious dose of the docetaxel/capecitabine combination
時間枠：2 years
|
2 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Charles L Vogel, MD、Cancer Research Network, Inc
- スタディチェア：Elizabeth Tan-Chiu, MD、Cancer Research Network, Inc.
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
- CRN-003
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