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Clinical Trials/NCT00954876
NCT00954876WithdrawnPhase 2

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 Institute2 sites in 1 countryStarted: August 2009Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Withdrawn
Locations
2
Primary Endpoint
Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Study of Capecitabine and Cetuximab as... | Clinical Trial