Clinical trial · Interventional
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 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study halted prematurely, prior to enrollment of first participant
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine and cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary objective is to assess PFS in patients with WT KRAS CRC treated with the combination regimen of capecitabine and cetuximab
- timeFrame
- 18 months
Secondary outcomes (4)
- measure
- To assess the response rate in patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
- timeFrame
- 18 months
- measure
- To assess the overall survival rate among patients with metastatic WT KRAS CRC treated with capecitabine and cetuximab
- timeFrame
- 18 months
- measure
- To characterize the toxic effects and AEs of the combination regimen of capecitabine and cetuximab in this patient population
- timeFrame
- every three months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available