An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
Cetuximab, a chimeric immunoglobulin G1 (IgG1) monoclonal antibody, has been found to
potentiate the effects of chemotherapy and radiotherapy in experimental systems. The
findings from clinical trials suggest a favorable risk-benefit ratio of the combination of
irinotecan or oxaliplatin, infusional 5-FU/FA and biweekly cetuximab, and support the
current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a
combination partner for those regimens in subjects with KRAS wild-type mCRC in the
first-line setting. The purpose of this study is to generate post marketing surveillance
(PMS) data for cetuximab in first-line mCRC, which is mandated by the Licensing Authorities.
This is an open-label, non-randomized, prospective, multicentric Phase IV study evaluating
FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type
metastatic CRC. The study plans to enroll 100 subjects with KRAS wild type CRC at 20 centres
across India. Tumour status, physical and laboratory examinations will be performed during
the baseline visit. Subjects will be administered FOLFIRI/ FOLFOX and cetuximab according to
the clinical condition in the following treatment visits. Regular safety assessments and all
adverse events (AEs) will be documented throughout and until the end-of-study visit. The
outcome of AEs ongoing at the final tumour assessment visit will be followed up at the
end-of-study visit (If possible, 6 weeks after the last administration of study medication
but before second-line anticancer treatment, and not earlier than 30 days after the end of
study treatment). Skin toxicity present at the end-of-study visit will be followed up until
outcome is known.
- To evaluate the safety and tolerability of Cetuximab in combination with standard
chemotherapy such as FOLFOX or FOLFIRI as first-line therapy of patients with KRAS
wild-type metastatic colorectal cancer.
- To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as
first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Observational Model: Cohort, Time Perspective: Prospective
Safety and tolerability evaluated based on the incidence and severity of AEs.
From baseline to follow-up visit for any ongoing AEs
Rajiv Rana, MD
Merck Ltd., India
India: Drugs Controller General of India