Metastatic Colorectal Cancer
Conditions
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.
Interventions
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
Eli Lilly and Company
Translational Genomics Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Metastatic colorectal cancer * Tumor classified WT KRAS * At least 18 yrs of age * ECOG PS 0,1 or 2 * Evidence of adequate organ function * Measurable disease per RECIST criteria * Have at least two of the following criteria: * Age \> 65 years * ECOG PS 1 or 2 * Serum Albumin \< or equal to 3.5g/dL * Prior RT to abdomen or pelvis * Stopped first-line combination systemic chemotherapy \< 6 weeks duration
Exclusion criteria
* Tumors classified as KRAS mutation * Prior therapy with cetuximab, panitumumab or other agent that targets EGFR * Prior exposure to any biologic * Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU) * Known DPD deficiency * Uncontrolled angina or a myocardial infarction within the previous 12 months * Concurrent severe uncontrolled medical illness * Known uncontrolled CNS metastases * Bowel disease associated with chronic diarrhea * Major surgery within 28 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab | 18 months |
| To assess the overall survival rate among 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 |
| To perform exploratory analyses of serum and tumor biomarkers (EGFR mutations and genotyping) on toxicity and efficacy. | 1 year after study closure |
Countries
United States
Outcome results
None listed