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

Terminated

• Conditions: Colorectal Neoplasms

• Registration Number: NCT01134666
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Study Timeline

• Study Start: 2009-11-30
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-06-02
• Primary Completion: 2013-07-31
• Study Completion: 2014-08-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability evaluated based on the incidence and severity of AEs.	From baseline to follow-up visit for any ongoing AEs

Secondary Outcome Measures

Name	Time	Method
Response rate	Baseline to End-of-Study Visit	Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)

Trial Locations

Locations (40)

Indo- American Cancer Institute & Research Centre; 🇮🇳 Hyderabad, Andhra Pradesh, India

NVS Ramakrishna's Clinic; 🇮🇳 Hyderabad, Andhra Pradesh, India

Dr. Nikhil's Clinic; 🇮🇳 Secunderabad, Andhra Pradesh, India

Nikhil Gharyalpatil's Clinic; 🇮🇳 Secunderabad, Andhra Pradesh, India

Ravi Kumar's Clinic; 🇮🇳 Hyderabad, Andrapradesh, India

Ambaa Hospitals; 🇮🇳 Hyderabad, Andrapradesh, India

Swarna Sai Hospital; 🇮🇳 Hyderabad, Andrapradesh, India

Manipal Centre For Clinical Research; 🇮🇳 Mangalore, Bangalore, India

Medical College Calicut; 🇮🇳 Kerala, Calicut, India

Hemato Oncology Clinic; 🇮🇳 Ahmedabad, Gujarat, India

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