Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, 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 colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Avastin, Irinotecan, High Dose 24 Hour Continuous Intravenous Infusion of Floxuridine and Leucovorin in Patients With Previously Untreated Metastatic Colorectal Cancer|
- Overall Survival up to 2 Years [ Time Frame: 2 years ] [ Designated as safety issue: No ]Percentage of patients with overall survival times of up to 2 years
- Response Rate (Complete Response and Partial Response) [ Time Frame: 2 years ] [ Designated as safety issue: No ]Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0
- Median Progression-free Survival in Months [ Time Frame: 2 years ] [ Designated as safety issue: No ]Median number of months subjects achieved progression-free survival
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm||Biological: bevacizumab Drug: floxuridine Drug: irinotecan hydrochloride Drug: leucovorin calcium Procedure: adjuvant therapy Procedure: neoadjuvant therapy|
- Determine whether irinotecan hydrochloride, floxuridine, leucovorin calcium, and bevacizumab improves overall survival of patients with stage IV colorectal cancer.
- Estimate response rate (complete response and partial response), time to response, and progression-free survival of patients treated with this regimen.
- Estimate the resectability rate in patients treated with this regimen.
- Evaluate the safety and toxicity of this regimen.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients receive bevacizumab IV over 90 minutes on days 1 and 22 and irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 24 hours, and high-dose floxuridine IV over 24 hours on days 1, 8, 22, and 29. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are evaluated after completion of every 2 courses of therapy. Patients whose disease is deemed operable at evaluation are referred to surgery.
Patients complete a quality of life assessment at baseline, every 6 weeks during study treatment, and periodically at follow-up.
After completion of study treatment, patients are followed every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449163
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Bach Ardalan, MD||University of Miami Sylvester Comprehensive Cancer Center|