Study of Cetuximab in Combination With mFOLFOX-6 (Oxaliplatin, Leucovorin, 5-FU) to Treat Colorectal Liver Metastatic Cancer Patients (CLIME)
The aim of this study is to explore whether cetuximab in combination with mFOLFOX6 as treatment could improve the resection rate in patients with KRAS wild-type, unresectable liver metastases of mCRC.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label, Uncontrolled, Multi-center, Phase II Study of Cetuximab in Combination With mFOLFOX-6 as First-line Treatment in Patients With KRAS Wild-type, Unresectable LIver Metastases of colorEctal Cancer|
- Resection rate (R0) [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle ] [ Designated as safety issue: No ]
- Response rate,Progression-free Survival,Overall Survival,R1 resection rate [ Time Frame: from the first cycle of treatment (day one) to six month after the last cycle ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: from the first cycle of treatment (day one) to six month after the last cycle ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Drug: Cetuximab; mFOLFOX6
Cetuximab (Erbitux): 500 mg/m2 iv gtt, D1
Oxaliplatin: 85 mg/m2 iv gtt over 2 hours, D1; leucovorin: 400 mg/m2 iv gtt , D1; 5-FU: 400 mg/m2 iv, 2400 mg/m2 civ46h
repeated every two weeks for 4.5 months(9 cycles)
During the last decade, chemotherapy in metastatic colorectal cancer (mCRC) has made considerable progress.However, approximately 25% of patients with colorectal cancer present with overt metastatic disease. In selected patients, synchronous or metachronous liver metastases (LM) can be resected in curative intention. Over the last 5 years there has been the recognition that preoperative, neoadjuvant, combination chemotherapy regimens, namely, 5-fluorouracil/folinic acid (5-FU/FA) in combination with either irinotecan or oxaliplatin can facilitate to downsize the initially unresectable LM and make the resection possible. The addition of targeted therapies might render them even more effective.
Due to these results, the investigators hypothesize that cetuximab in combination with mFOLFOX6 as treatment in patients with KRAS wild-type, unresectable liver metastases of mCRC may further improve clinical outcomes.
|Contact: Sanjun Cai, phDemail@example.com|
|Fudan University Shanghai Cancer Center||Recruiting|
|Shanghai, Shanghai, China|
|Contact: Wenhua Li, MD 8621-64175590 firstname.lastname@example.org|
|Principal Investigator:||Sanjun Cai, PhD||Fudan University|