Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery
A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine and bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab and to see how well they work in treating patients with pancreatic cancer that has been completely removed by surgery.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the safety of adjuvant, fixed-dose rate gemcitabine hydrochloride and bevacizumab in patients with completely resected pancreatic cancer.
- Determine the 1-year disease-free survival rate in patients treated with this regimen.
Secondary
- Determine the 1- and 2-year overall survival rates in these patients.
- Determine the median disease-free survival rate in these patients.
- Determine the median overall survival rate in these patients.
OUTLINE: This is an open-label, non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes followed by bevacizumab* IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity.
NOTE: *The first dose of bevacizumab is not administered until after 6 weeks have passed since surgery.
After completion of study therapy, patients are followed periodically for 18 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
研究の種類
入学 (予想される)
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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San Francisco、California、アメリカ、94115
- UCSF Helen Diller Family Comprehensive Cancer 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 or cytologically confirmed adenocarcinoma of the pancreas
Completely resected disease
Underwent 1 of the following procedures 3-8 weeks ago:
- Standard pancreaticoduodenectomy (for tumors of the pancreatic head)
- Distal pancreatectomy (for tumors of the pancreatic tail)
No grossly positive surgical margins
- Positive microscopic margins allowed
- Nonmeasurable disease
- No known CNS disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- CA 19-9 ≤ 2.5 times upper limit of normal (ULN)
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
- Platelet count ≥ 100,000/mm³
- INR ≤ 1.5 (except in patients receiving full-dose warfarin)
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL
- No clinically significant impairment of renal function
No postoperative complications, including any of the following:
- Wound dehiscence or infection
- Intra-abdominal abscess
- Pancreatic or biliary leak or fistula
- Grade 3 or 4 delayed hemorrhage (occurring > 5 days postoperatively)
- Bowel perforation
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess within the past 6 months
- No history of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates use of the study drugs or renders the patient at high risk of treatment-related complications
- No other cancer within the past 5 years except basal cell or squamous cell skin cancer
No history of serious systemic disease, including any of the following:
- Myocardial infarction or unstable angina within the past 12 months
- New York Heart Association class II-IV congestive heart failure
Unstable symptomatic arrhythmia requiring medication
- Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
- No history of stroke or transient ischemic attack
- No symptomatic peripheral vascular disease
- No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- No inadequately controlled hypertension (i.e., blood pressure > 150/100 mm Hg on antihypertensive medication)
- No prior hypertensive crisis or hypertensive encephalopathy
- No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 OR proteinuria ≥ 2+ by dipstick urinalysis OR protein > 1 g by 24-hour urine collection)
- No serious, nonhealing wound or ulcer
- No evidence of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for pancreatic cancer
- No prior systemic or investigational therapy for pancreatic cancer
- No major surgical procedure (except for resection of pancreatic cancer) or open biopsy within the past 28 days
- No fine-needle aspiration or core biopsy within the past 7 days
- No anticipated need for a major surgical procedure during study treatment
No concurrent newly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs)
- Concurrent chronic-dose NSAIDs for analgesia are 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:非ランダム化
- 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 |
|---|
|
Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0
|
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Disease-free survival rate at 1 year
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二次結果の測定
結果測定 |
|---|
|
Overall survival rate at 1 and 2 years
|
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Median disease-free survival rate at 1 and 2 years
|
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Median overall survival rate at 1 and 2 years
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協力者と研究者
捜査官
- スタディチェア:Andrew Ko, MD、University of California, San Francisco
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
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