JPRN-UMIN000013797已完成2 期
A Multicenter, Clinical Phase II study of FOLFOXIRI with Bevacizumab As First-line Therapy in Patients with Metastatic Colorectal Cancer. - Quadruplet treatment trove reveal outcome for Japanese Patient.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Previously treated with irradiation to bone marrow constituting 20% or more of irradiation field. 2. Untreated brain metastases or spinal cord compression or primary brain tumors. 3. History of CNS disease.[except for asymptomatic Lacunar stroke] 4. Requiring chronic systemic corticosteroid treatment. 5. Current or recent ongoing treatment with anticoagulants. 6. Clinically significant cardiovascular disease for example cerebrovascular accidents, myocardial infarction, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication. 7. Treatment with any investigational drug within 4 weeks. 8. Patient with Uncontrolled hypertension, Uncontrolled diabetes, Uncontrolled diarrhea->=grade 1 peripheral neuropathy, Active peptic ulcer, Non-healing wound, Clinically important diseases. 9. Major surgical procedure within 28 days prior to study treatment start, open biopsy, or significant traumatic injury, or anticipation of the need for major surgical procedure. 10. Lack of physical integrity of the upper gastrointestinal tract. 11. Pregnant women, lactating woman , positive by pregnancy test , wishing to become pregnant, and Sexually active males. 12. Hepatitis B or hepatitis C . Evidence of HIV infection. 13. Previous Chemotherapy for other organs. 14. Other active co-existing malignancies. 15. History / Presence of thrombosis within 1 year requiring medication. 16. History / Presence of paralytic ileus, obstruction or gastrointestinal perforation. 17. Malignant coelomic fluid required drainage. 18. History of allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications. 19. History of fluoropyrimidine severe side effects caused by DPD defect. 20. Interstitial pneumonitis or pulmonary fibrosis. 21. Evidence or requiring systemic treatment for Infectious disease. 22. Patient who is judged by the investigator to be inappropriate for study participation for any reason.
研究者
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已完成
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进行中（未招募）
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Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line RegimeSecond line treatment of patients with metastatic carcinoma of colon and rectumMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerMedDRA version: 9.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2007-006283-30-CZPfizer Inc, 235 East 42nd Street, New York, NY 10017, USA176
进行中（未招募）
不适用
Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line RegimeSecond line treatment of patients with metastatic carcinoma of colon and rectumMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerMedDRA version: 9.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2007-006283-30-BEPfizer Inc, 235 East 42nd Street, New York, NY 10017, USA176
进行中（未招募）
1 期
Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line RegimeSecond line treatment of patients with metastatic carcinoma of colon and rectumMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerMedDRA version: 9.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2007-006283-30-FRPfizer Inc, 235 East 42nd Street, New York, NY 10017, USA176
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