Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
An Intergroup Randomized Phase II Study of Bevacizumab (NSC 704865) or Cetuximab (NSC 714692) in Combination With Gemcitabine and in Combination With Chemoradiation (Capecitabine and Radiation) in Patients With Completely-Resected Pancreatic Carcinoma
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine, before and after capecitabine plus radiation and during capecitabine plus radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting.
II. To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in patients with resected pancreatic cancer.
III. To obtain tissue specimens from resections of patients enrolled on study for correlative studies and further evaluations.
SECONDARY OBJECTIVES:
I. To evaluate disease-free and overall survival for patients receiving either cetuximab or bevacizumab in combination with gemcitabine before and after capecitabine plus radiation.
II. To assess the safety profile for patients receiving either capecitabine plus cetuximab plus radiation, or capecitabine plus bevacizumab plus radiation.
III. To correlate changes in serum amphiregulin and TGF alpha to survival, DFS and rash for patients receiving cetuximab.
IV. To determine the 2-year survival rate for patients receiving either cetuximab plus gemcitabine before and after capecitabine plus cetuximab plus radiation, or bevacizumab plus gemcitabine before and after capecitabine plus bevacizumab plus radiation.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to degree of prior resection of the pancreatic tumor (R0 vs R1). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
Arm II: Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
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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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Eastern Cooperative Oncology Group
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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:
- Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma
- Patients must have had all gross disease resected (R0 or R1 resection)
- Patients undergoing an R2 resection are not eligible
- Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer and must have had no prior EGFR/VEGF inhibition
- Patient must have ECOG performance status of 0-2
- Leukocytes >= 3,000/μL
- ANC >= 1,500/μL
- Platelets >= 100,000/μL
- Total bilirubin Within normal institutional limits
- AST (SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal
- Creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
- Patients must be > 4 weeks and =< 8 weeks post-surgery at time of study registration (may be up to 10 weeks post-surgery prior to start of study therapy)
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception prior to study entry
- Women must not be pregnant or breast-feeding; all agents used in this study as well as radiation therapy to the abdomen have the potential for teratogenic or abortifacient effects; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- Patients must not be receiving any other investigational agents
- Patients with known metastases are not eligible
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, bevacizumab or other agents used in the study are not eligible
- Patients with wounds that have not fully healed are not eligible
- Patients must not have cardiac arrhythmia
- Patients must have no known HIV infection
- Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma
- Patients with psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude them from meeting the study requirements are not eligible
- Patients requiring full dose anticoagulation are not eligible
- Patients with a history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) are not eligible
Patients with a history of the following within twelve months of study entry are not eligible:
- Arterial thrombembolic events
- Unstable angina
- Myocardial infarction
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：ランダム化
- 介入モデル：並列代入
- 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：Arm I (cetuximab, gemcitabine, capecitabine, radiation)
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10.
Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
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相関研究
与えられた IV
他の名前：
与えられた IV
他の名前：
経口投与
他の名前：
放射線治療を受ける
他の名前：
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実験的：Arm II (bevacizumab, gemcitabine, capecitabine, radiation)
Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, and 23.
Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I.
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相関研究
与えられた IV
他の名前：
与えられた IV
他の名前：
経口投与
他の名前：
放射線治療を受ける
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 |
|---|---|---|
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Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy
時間枠：Every 2 weeks while on treatment and for 30 days after the end of treatment
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Specific toxicities to be monitored pursuant to the primary endpoint include:
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Every 2 weeks while on treatment and for 30 days after the end of treatment
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Two-year Overall Survival Rate
時間枠：Assessed every 3 months for 2 years
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Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.
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Assessed every 3 months for 2 years
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Two-year Disease-free Survival (DFS)
時間枠：Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years
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Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).
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Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 years
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協力者と研究者
捜査官
- 主任研究者：Jordan Berlin、Eastern Cooperative Oncology Group
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
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2012-02969 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- U10CA021115 (米国 NIH グラント/契約)
- CALGB-ECOG-E2204
- SWOG-ECOG-E2204
- ECOG-E2204
- NCCTG-ECOG-E2204
- E2204 (その他の識別子：CTEP)
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