Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab, oxaliplatin, and docetaxel.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine time to treatment failure and overall survival of patients treated with this regimen.
- Determine the changes in general and disease-specific quality of life, in terms of response to treatment, in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 120 minutes, and docetaxel IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 18-23 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
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-0942
- University of Michigan Comprehensive Cancer Center
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Detroit、Michigan、アメリカ、48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit、Michigan、アメリカ、48201
- Veterans Affairs Medical Center - Detroit
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Ohio
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Columbus、Ohio、アメリカ、43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical 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 gastric or gastroesophageal junction adenocarcinoma
- Locally advanced unresectable or metastatic disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan
- Bone metastases, ascites, or pleural effusions are not considered measurable disease
- Evaluable disease must be present outside previously irradiated field
- No CNS or brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- SWOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 mg/dL
- No evidence of bleeding diathesis or coagulopathy
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ ULN
- INR < 1.5
Renal
- Creatinine < 2.0 mg/dL
- Urine protein:creatinine ratio < 1.0
Cardiovascular
- No history of deep venous thrombosis requiring anticoagulation
- No active angina
- No myocardial infarction within the past year
- No cerebrovascular accident within the past year
- No uncontrolled hypertension (systolic blood pressure [BP] > 170 mm Hg and/or diastolic BP > 100 mm Hg) despite medical management
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No peripheral neuropathy > grade 1
- No history of allergy to any of the study drugs or drugs formulated with polysorbate 80
- No known HIV infection
- No active peptic ulcer disease
- No serious non-healing wound, ulcer, or bone fracture
- No unresolved bacterial infection requiring antibiotics
- No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior chemotherapy for gastric cancer unless disease relapsed > 6 months after completion of non-taxane adjuvant chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since radiotherapy
Surgery
- At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement)
- No concurrent surgery
Other
- At least 4 weeks since prior and no concurrent participation in another experimental drug trial
- No concurrent full-dose anticoagulation
- No concurrent experimental drugs
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, Oxaliplatin & Bevacizumab
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes.
If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
|
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes.
If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
他の名前：
Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70
mg/m(2), IV over 60 minutes, day 1 of each cycle;
他の名前：
Must be administered 3rd after Bevacizumab and Docetaxel.
75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
他の名前：
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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 |
|---|---|---|
|
Time to Progression
時間枠：After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
|
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
|
After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response Rate by RECIST Criteria
時間枠：After every 2 cycles (1 cycle =21 days)
|
Percentage of Participants with response by RECIST criteria until progression
|
After every 2 cycles (1 cycle =21 days)
|
|
Toxicity Profile
時間枠：At 21 days following completion of study treatment
|
Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.
|
At 21 days following completion of study treatment
|
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Time to Treatment Failure
時間枠：Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
Time to treatment failure using the Kaplan-Meier method
|
Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
|
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Overall Survival
時間枠：Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
|
Overall survival using the Kaplan-Meier method
|
Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
|
協力者と研究者
捜査官
- 主任研究者：Philip A. Philip, MD, PhD, FRCP、Barbara Ann Karmanos Cancer Institute
- 主任研究者：Basil El-Rayes, MD、Barbara Ann Karmanos Cancer Institute
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 (実際)
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
- CDR0000441641
- P30CA022453 (米国 NIH グラント/契約)
- WSU-D-2840
- UMCC-2005-052
- AVENTIS-WSU-D-2840
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