NCT00066846已完成2 期
A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (Avastin®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 33
研究概览
简要总结
RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.
详细描述
OBJECTIVES:
- Determine the response rate of patients treated with bevacizumab, fluorouracil, and leucovorin calcium for stage IV colorectal cancer that has progressed after standard chemotherapy.
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the safety of administering "bolus" and continuous infusion fluorouracil and leucovorin calcium in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment regimens.
- Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks) and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1, 8, 15, 22, 29, and 36.
- Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and 5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29, 30, 43, and 44.
For both regimens, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed colorectal adenocarcinoma
- •Stage IV (metastatic) disease
- •Not curable by surgery or radiotherapy
- •Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria:
- •Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy
- •Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL (transfusion allowed)
- •No evidence of bleeding diathesis or coagulopathy
- •Bilirubin no greater than 1.5 mg/dL
- •AST less than 5 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 5 times ULN
- •PT and INR no greater than 1.5 times ULN
- •PTT no greater than ULN
- •Creatinine no greater than 1.5 times ULN
- •Proteinuria less than grade 1 OR
- •Proteinuria less than 500 mg/24 hours
- •Cardiovascular
- •No prior stroke
- •No uncontrolled high blood pressure
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No myocardial infarction within the past 6 months
- •No New York Heart Association class III or IV heart disease
- •No thromboembolism within the past 6 months
- •Chemonaive
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after study participation
- •No significant traumatic injury within the past 6 weeks
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents
- •No active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture
- •No CNS disease, including either of the following:
- •Primary brain tumor
- •Seizures not controlled with standard medical therapy
- •PRIOR CONCURRENT THERAPY:
- 另有 19 项未显示
排除标准
- 未提供
研究者
研究点 (33)
Loading locations...
相似试验
已完成
1 期
Bevacizumab in Treating Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsLeukemiaNCT00022048Stanford University
已完成
2 期
Bevacizumab, Docetaxel, and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck CancerHead and Neck CancerNCT00281840Case Comprehensive Cancer Center30
已完成
1 期
Bevacizumab, Everolimus, and Erlotinib in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00276575Herbert Hurwitz, MD65
已完成
1 期
Bevacizumab in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00416637Herbert Hurwitz, MD27
已完成
1 期
Bevacizumab, Fluorouracil, and Hydroxyurea Plus Radiation Therapy in Treating Patients With Advanced Head and Neck CancerMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the LipRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Basal Cell Carcinoma of the LipStage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage III Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage III Lymphoepithelioma of the NasopharynxStage III Lymphoepithelioma of the OropharynxStage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Basal Cell Carcinoma of the LipStage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IV Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IV Lymphoepithelioma of the NasopharynxStage IV Lymphoepithelioma of the OropharynxStage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityUntreated Metastatic Squamous Neck Cancer With Occult PrimaryNCT00023959National Cancer Institute (NCI)39