Colorectal Neoplasms
Conditions
Keywords
Colorectal neoplasms, Intestinal neoplasms, Neoplasms, cetuximab, Erbitux
Brief summary
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.
Detailed description
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. OBJECTIVES Primary Objective: * 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. Secondary Objective: * To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Interventions
DRUGCetuximab
FOLFOX Oxaliplatin 100 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 FOLFIRI Irinotecan 180 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 CETUXIMAB Cetuximab administered at loading dose of 400 mg/m2/week over 120 min followed by maintenance dose of 250 mg/m2/ week over 60 min, till disease progression or dose limiting toxicity
Sponsors
Merck Ltd., India
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC) * Subjects with KRAS wild-type status of tumour tissue * Chemotherapy naïve subjects * Subject who have signed written informed consent (as per institutional protocol)
Exclusion criteria
* As per summary of product characteristics of cetuximab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability evaluated based on the incidence and severity of AEs. | From baseline to follow-up visit for any ongoing AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Baseline to End-of-Study Visit | Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS) |
Countries
India
Outcome results
None listed