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.
|Colorectal Cancer||Biological: Bevacizumab Drug: Floxuridine Drug: Irinotecan Drug: Leucovorin||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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 ]Percentage of patients with overall survival times of up to 2 years
- Response Rate (Complete Response and Partial Response) [ Time Frame: 2 years ]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 ]Median number of months subjects achieved progression-free survival
- Rate of Toxicity in Study Participants [ Time Frame: 2 years ]Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.
|Actual Study Start Date:||March 1, 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Combination Chemotherapy and Bevacizumab
Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29:
Other Name: AvastinDrug: Floxuridine
Other Name: 5-fluorodeoxyuridineDrug: Irinotecan
Other Names:Drug: Leucovorin
Other Name: Leucovorin calcium
For the purpose of this study treatment cycle consist of six weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29 according to the schedule. There will be no treatment delivered on weeks 3 & 6 (Days 15 and 36).
Disease will be evaluated by CT scan at the completion of every two cycles. Patients with complete response (CR), or partial response (PR), will be evaluated for possible surgical resection. Patients who become operable will continue to be evaluated for survival and disease relapse. Patients with stable disease (SD), and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449163
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Bach Ardalan, MD||University of Miami|