Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer
Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic breast cancer treated with docetaxel, capecitabine, and bevacizumab as first-line chemotherapy.
Secondary
- Determine time to disease progression in patients treated with this regimen.
- Determine survival of patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
研究の種類
入学 (実際)
段階
- フェーズ2
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 or cytologically confirmed invasive breast cancer
Clinical evidence of metastatic disease
- No bone metastases as the only evidence of metastasis
Measurable disease
At least 1 lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan
- Lesions on chest x-ray allowed provided they are clearly defined and surrounded by aerated lung
- Clincal lesions only considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)
- Target lesion must not have been exposed to prior radiotherapy unless disease has progressed since completion of radiotherapy
The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis or pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- No HER2/neu-positive tumors by immunohistochemistry or amplified fluorescence in situ hybridization unless disease has progressed after trastuzumab (Herceptin®)-containing therapy alone or with antiestrogen hormonal therapy for metastatic disease OR trastuzumab is contraindicated
- Prior breast cancer allowed
- No prior or active brain metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
- No bleeding diathesis or uncontrolled coagulopathy
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- AST and ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
- AST and ALT ≤ 5 times ULN AND alkaline phosphatase normal
Renal
- Creatinine clearance ≥ 30 mL/min
- No proteinuria OR
- Protein < 1 g by 24-hour urine collection
- No nephrotic syndrome
Cardiovascular
No uncontrolled hypertension (i.e., blood pressure > 160/90 mm Hg on ≥ 2 different observations ≥ 5 minutes apart)
- Blood pressure < 140/90 mm Hg on ≥ 3 different observations over ≥ 14 days, for patients who recently began or adjusted anti-hypertensive medication
- No atrial or venous thrombosis within the past month
No clinically significant heart disease, including any of the following:
- Congestive heart failure
- Symptomatic coronary artery disease
- Uncontrolled cardiac arrhythmias
- Unstable angina
- No myocardial infarction within the past 12 months
- No history of cerebrovascular accident
Pulmonary
- No hemoptysis within the past 6 months
Gastrointestinal
- No lack of physical integrity of the upper gastrointestinal tract
- No malabsorption syndrome
- Able to receive oral medication
Other
- No other stage III or IV invasive malignancy requiring treatment within the past 5 years
- No pre-existing peripheral neuropathy > grade 1
- No history of allergy or hypersensitivity to study drugs, agents that are chemically similar to study drugs, or drugs that contain polysorbate 80
- No prior severe reaction to fluoropyrimidines
- No known hypersensitivity to fluorouracil
- No known dihydropyrimidine dehydrogenase deficiency
- No active infection
- No significant medical condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No other concurrent biologic therapy
Chemotherapy
- Prior adjuvant or neoadjuvant chemotherapy allowed for primary disease
- No prior chemotherapy for metastatic disease
- More than 4 weeks since prior cytotoxic chemotherapy
- More than 6 months since prior taxanes (e.g., docetaxel or paclitaxel)
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- Prior antiestrogen hormonal therapy allowed in the adjuvant or metastatic setting
Radiotherapy
- See Disease Characteristics
More than 4 weeks since prior radiotherapy to a target lesion
- Prior single-dose palliative radiotherapy allowed within the past 4 weeks
- No concurrent radiotherapy
Surgery
- More than 4 weeks since prior major surgery
Other
More than 2 weeks since prior aspirin, anticoagulants, or thrombolytic agents
- Concurrent low-dose warfarin (1 mg/day) to maintain patency of vascular access device allowed
- More than 4 weeks since prior investigational agents
- No concurrent aspirin, anticoagulants, or thrombolytic agents
- No concurrent participation in another clinical trial involving investigational agents or procedures
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:docetaxel + bevacizumab + capecitabine
Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. |
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 |
---|---|
Confirmed tumor response (complete or partial) rate as measured by RECIST
時間枠:Up to 5 years
|
Up to 5 years
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
無増悪生存
時間枠:5年まで
|
5年まで
|
全生存
時間枠:5年まで
|
5年まで
|
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 (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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NCCTG-N0432
- NCI-2012-02617 (レジストリ識別子:CTRP (Clinical Trials Reporting System))
- CDR0000377886 (レジストリ識別子:PDQ (Physician Data Query))
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。
乳がんの臨床試験
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