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

June 8, 2017 updated by: Merck KGaA, Darmstadt, Germany
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India, 110055
        • Nothern Railway Central Hospital
      • Delhi, India, 110076
        • Indraprastha Apollo Hospital
      • Delhi, India, 110092
        • Shanti Mukand Hospital
      • Delhi, India, 110096
        • Dharamshila Cancer Hospital & Research Centre
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Indo- American Cancer Institute & Research Centre
      • Hyderabad, Andhra Pradesh, India, 500063
        • NVS Ramakrishna's Clinic
      • Secunderabad, Andhra Pradesh, India, 500025
        • Dr. Nikhil's Clinic
      • Secunderabad, Andhra Pradesh, India, 500025
        • Nikhil Gharyalpatil's Clinic
    • Andrapradesh
      • Hyderabad, Andrapradesh, India, 500001
        • Ravi Kumar's Clinic
      • Hyderabad, Andrapradesh, India, 500008
        • Ambaa Hospitals
      • Hyderabad, Andrapradesh, India, 500059
        • Swarna Sai Hospital
    • Bangalore
      • Mangalore, Bangalore, India, 575 001
        • Manipal Centre For Clinical Research
    • Calicut
      • Kerala, Calicut, India, 673016
        • Medical College Calicut
    • Gujarat
      • Ahmedabad, Gujarat, India, 380009
        • Hemato Oncology Clinic
    • Karnataka
      • Hubli, Karnataka, India, 580020
        • Kattimani Oncology Clinic
    • Kashmir
      • Srinagar, Kashmir, India, 190001
        • SKIMS
      • Srinagar, Kashmir, India, 190010
        • S. K. I. M. S.
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462001
        • Dr. T. P. Sahoo's Clinic
    • Maharashtra
      • Mumbai, Maharashtra, India, 400014
        • BND Onco Centre
      • Mumbai, Maharashtra, India, 400071
        • Joy Hospital
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic
    • Mizoram
      • Aizwal, Mizoram, India, 796 009
        • Grace Nursing Home
    • Mumbai
      • Bandra, Mumbai, India, 400050
        • Lilavati Hospital
      • Mahim, Mumbai, India, 400016
        • S.L.Raheja Hospital
    • New Delhi
      • Delhi, New Delhi, India, 110044
        • Apollo Cancer Institute
      • Delhi, New Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute & Research
    • Punjab
      • Amritsar, Punjab, India, 143004
        • Fortis Escorts Hospital
      • Chandigarh, Punjab, India, 160101
        • Dr. Rajeev Bedi's Clinic
      • Ludhiana, Punjab, India, 141001
        • D.M.C Hospital
      • Mohali, Punjab, India, 160071
        • IVY Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • SMS Hospital
      • Jaipur, Rajasthan, India, 302004
        • Cancer Clinic
      • Jaipur, Rajasthan, India, 302006
        • Bhagwan Mahaveer Cancer Hospital
      • Jaipur, Rajasthan, India, 302030
        • Bhagwan Mahaveer Cancer Hospital & Research Centre
      • Jodhpur, Rajasthan, India, 3420003
        • Vyas Cancer Care
    • Tamilnadu
      • Trivandrum, Tamilnadu, India, 695011
        • TC 14/ 764 Sreemangalam
    • Uttar Pradesh
      • Ghaziabad, Uttar Pradesh, India, 201014
        • Shati Gopal Hospital
      • Lucknow, Uttar Pradesh, India, 226007
        • Annapurna Medical and Cancer Relief Society
    • West Bengal
      • Kolkata, West Bengal, India, 700026
        • Chittaranjan National Cancer Institute
      • Kolkata, West Bengal, India, 700054
        • Apollo Gleneagles Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with KRAS wild-type CRC receiving FOLFOX/FOLFIRI and cetuximab in India.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability evaluated based on the incidence and severity of AEs.
Time Frame: From baseline to follow-up visit for any ongoing AEs
From baseline to follow-up visit for any ongoing AEs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Baseline to End-of-Study Visit
Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)
Baseline to End-of-Study Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Ltd., India

Investigators

  • Study Director: Rajiv Rana, MD, Merck Ltd., India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2009

Primary Completion (Actual)

July 31, 2013

Study Completion (Actual)

August 5, 2014

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 062202-517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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