Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00449163|
Recruitment Status : Terminated (Study terminated by University of Miami Institutional Review Board)
First Posted : March 19, 2007
Results First Posted : February 28, 2013
Last Update Posted : May 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: Bevacizumab Drug: Floxuridine Drug: Irinotecan Drug: Leucovorin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 1, 2006|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449163
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Bach Ardalan, MD||University of Miami|