Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer
This study has been completed.
Information provided by (Responsible Party):
First received: July 26, 2007
Last updated: November 1, 2013
Last verified: November 2013
The purpose of this study is evaluate the treatment effect of panitumumab plus FOLFIRI as first line therapy in metastatic colorectal cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm Multicentre Phase II Study of Panitumumab in Combination With Irinotecan/5-fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Objective response rate [ Time Frame: Evaluated every 8 weeks through to week 48 of the study. Every 3 months thereafter until radiographic disease progression. ] [ Designated as safety issue: No ]Incidence of either a confirmed complete or partial response.
|Study Start Date:||April 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Single-arm: Panitumumab in combination with Irinotecan, 5-fluorouracil, Leucovorin (FOLFIRI)
6mg/kg panitumumab (IV) on day 1 of each 14 day treatment cycle just prior to administration of chemotherapy (FOLFIRI) . Number of cycles: until progression or unacceptable toxicity develops.
Other Name: VectibixDrug: FOLFIRI
On day 1 of each 14 day treatment cycle FOLFIRI is administered just after 6mg/kg panitumumab. Number of cycles : until progression or unacceptable toxicity develops
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