NCT00885885

Safety and Efficacy Study of FOLFOX4+Panitumumab vs.FOLFIRI+Panitumumab in Subjects WT KRAS Colorectal Cancer and Liver-only Metastases

An Open Label Randomized, Multi-Centre Exploratory Phase II Study to Evaluate the Efficacy and Safety of the Combination of Panitumumab With FOLFOX 4 Chemotherapy or Panitumumab With FOLFIRI Chemotherapy in Subjects With Wild- Type KRAS Colorectal Cancer and Liver-only Metastases.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab+FOLFOX-4	Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFOX 4 chemotherapy will be administered on day 1 of each 14-day treatment cycle: * Oxaliplatin 85mg/m2 as a 120 minute infusion on day 1 of each cycle * Folinic acid 200mg/m2 as a 120 minute infusion on days 1 and 2 * A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on days 1 and 2 * 5-FU at 600mg/m2 as a continuous infusion of 22 hour infusion on days 1 and 2
DRUG	Panitumumab+FOLFIRI	Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFIRI chemotherapy will be administered on day 1 of each 14-day treatment cycle: * Irinotecan 180 mg/m2 will be administered over 90 minutes ± 15 minutes on day 1 of each cycle * Folinic acid 400 mg/m2 will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing * A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on day 1 * 5-FU at 2400 mg/m2 continuous intravenous infusion over 46-hour ± 2-hour on day 1 of each cycle.

Timeline

• Start date: 2009-05-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2009-04-22
• Last updated: 2017-08-01

Locations

1 site across 1 country: Spain