Phase II, Multi-Center, Open-Label, Prospective Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type KRAS Colorectal Cancer Who Are Considered Nonoptimal Candidates or Are Intolerant to a First-Line Oxaliplatin/Irinotecan Regimen

Translational Genomics Research Institute1 site in 1 countryAugust 2009

ConditionsMetastatic Colorectal Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Metastatic Colorectal Cancer
Sponsor: Translational Genomics Research Institute
Locations: 1
Primary Endpoint: Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

January 2010

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Translational Genomics Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab

Time Frame: 18 months

Secondary Outcomes

To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy.(1 year after study closure)
To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab(18 months)
To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab(18 months)
To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population(every three months)