Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression
Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose and recommended phase II dose of erlotinib when combined with trastuzumab (Herceptin) as first-line therapy in women with metastatic breast cancer associated with HER2/neu overexpression. (Phase I closed to accrual as of 01/2004)
- Determine the safety profile of this regimen in these patients.
- Determine the rate and duration of objective response in patients treated with this regimen.
- Determine the pharmacologic behavior of this regimen in these patients.
- Determine time to disease progression and duration of survival in patients treated with this regimen.
- Correlate the antitumor activity of this regimen with epidermal growth factor receptor expression in these patients.
OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of 01/2004).
Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion (closed to accrual as of 01/2004) and 27-81 patients will be accrued for the phase II portion of this study.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
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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:
- Women aged > 18 years
- Histologically documents metastatic breast cancer
- HER2 positive using Fluorescence In Situ Hybridization (FISH)
- For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.
- For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- A life expectancy of > 3 months
- Use of effective means of contraception
Exclusion Criteria:
- For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed.
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 |
|---|---|
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実験的：treatment
please see intervention description
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Day 1 4mg/kg IV 2 mg/kg IV weekly.
他の名前：
100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily.
Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.
他の名前：
|
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 |
|---|---|---|
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The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.
時間枠：5 years
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Complete Response: The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission. Partial Response: A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission. |
5 years
|
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Recommended Dose for Phase II
時間枠：treatment period
|
treatment period
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Duration of Objective Response
時間枠：5 years
|
5 years
|
|
Incidence of Adverse Events
時間枠：5 years
|
5 years
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Serum Concentration of Herceptin at Specified Time-points.
時間枠：4 months
|
4 months
|
協力者と研究者
出版物と役立つリンク
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
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