Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer
Phase 2
Withdrawn
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- NCT00954876
- Lead Sponsor
- Translational Genomics Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab 18 months
- Secondary Outcome Measures
Name Time Method To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab 18 months 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 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the synergy between capecitabine and cetuximab in KRAS wild-type colorectal cancer?
How does the capecitabine-cetuximab regimen compare to oxaliplatin/irinotecan in metastatic KRAS wild-type colorectal cancer outcomes?
Which biomarkers correlate with response to cetuximab-based therapy in KRAS wild-type metastatic colorectal cancer patients?
What are the key adverse events associated with capecitabine and cetuximab combination therapy in non-optimal CRC patients?
Are there alternative EGFR-targeting agents or combination strategies for KRAS wild-type metastatic colorectal cancer treatment?
Trial Locations
- Locations (1)
Evergreen Hematology & Oncology
🇺🇸Spokane, Washington, United States
Evergreen Hematology & Oncology🇺🇸Spokane, Washington, United States