PRIME: Panitumumab Randomized Trial In Combination with Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy
Study Details
The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer
Protocol Summary
Progression-free survival
Timeframe: From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.
Overall survival
Timeframe: From randomization until the data cutoff date of 28 August 2009. Maximum time on follow-up was 144 weeks.
Percentage of participants with an objective response
Timeframe: Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
Time to progression
Timeframe: From randomization until the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks
Duration of response
Timeframe: Every 8 weeks until disease progression up to the data cut-off date of 30 September 2008; Maximum follow-up time was 109 weeks.
Number of participants with adverse events
Timeframe: From randomization until the data cut-off date of 28 August 2009; Maximum time on follow-up was 144 weeks.