Folfox-B Study for Patients With Colorectal Liver Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00508872|
Recruitment Status : Terminated (Slow accrual, study terminated.)
First Posted : July 30, 2007
Results First Posted : November 4, 2010
Last Update Posted : August 1, 2012
- To evaluate the efficacy of the use of the combination of oxaliplatin, 5-fluorouracil, leucovorin and bevacizumab (FOLFOX-B) in patients with unresectable colorectal liver metastases, with the objective to downstage hepatic disease and enable complete resection of residual disease.
- To evaluate the resection rate in patients with initially unresectable hepatic colorectal metastases downstaged with FOLFOX-B. Complete resection of all liver lesions is the goal.
- To evaluate the probability of complete response, partial response or stable disease.
- To evaluate the proportion of patients who are resected, and the proportion of patients achieving an R0 resection (among those receiving surgery).
- To correlate survival with downstaging and resection based on metastatic colorectal prognostic score.
- To evaluate the disease-free survival and overall survival.
- To evaluate the positron emission tomography response rate.
- To explore correlations of clinical response with telomerase and hTERT expression.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Liver Metastases||Drug: 5-Fluorouracil Drug: Bevacizumab Drug: Leucovorin Drug: Oxaliplatin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-Institution Phase II Trial of Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab (Folfox-B) for Initially Unresectable Colorectal Liver Metastases: Downstaging Followed By Hepatic Resection|
|Study Start Date :||November 2005|
|Primary Completion Date :||June 2009|
|Study Completion Date :||June 2009|
FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
400 mg/m^2 IV over 15 minutes, followed by 2400 mg/m^2 IV Over 46 Hours
Other Names:Drug: Bevacizumab
5 mg/kg IV Over 30-90 Minutes On Day 1 Every 14 Days
Other Names:Drug: Leucovorin
400 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
Other Names:Drug: Oxaliplatin
85 mg/m^2 IV Over 2 Hours On Day 1 Every 14 Days
Other Name: Eloxatin
- Complete Gross Resection Rate [ Time Frame: Over 4 year study period ]Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508872
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eddie Abdalla, MD||M.D. Anderson Cancer Center|