Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer
NCT00954876 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2022-10-20
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.
Conditions
Interventions
- DRUG
-
capecitabine and cetuximab
Cetuximab 500 mg/m2 IV infusion over 1-2 hours Once every 2 weeks Capecitabine 1500 mg/m2 PO BID Days 1-7 followed by 7 days of no treatment and repeated every 2 weeks
Sponsors & Collaborators
- collaborator INDUSTRY
-
Translational Genomics Research Institute
lead OTHER
Principal Investigators
-
Ramesh Ramanathan, M.D. · Translational Genomics
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-08-31
- Primary Completion
- 2010-01-31
- Completion
- 2010-01-31
Countries
- United States
Study Locations
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