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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Ltd., India
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01134666
First received: May 28, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Drug: Cetuximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Safety and tolerability evaluated based on the incidence and severity of AEs. [ Time Frame: From baseline to follow-up visit for any ongoing AEs ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: Baseline to End-of-Study Visit ] [ Designated as safety issue: No ]
    Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)


Biospecimen Retention:   Samples With DNA

Whole Blood and Tissue


Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    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
    Other Name: Erbitux
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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134666

Locations
India
Indo- American Cancer Institute & Research Centre Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Dr. Palanki S. Dattatreya    91-9440591396    satya_palanki@rediffmail.com   
NVS Ramakrishna's Clinic Recruiting
Hyderabad, Andhra Pradesh, India, 500063
Contact: Dr. N V S Ramkrishna    9949341112    rnalla@gmail.com   
Nikhil Gharyalpatil's Clinic Recruiting
Secunderabad, Andhra Pradesh, India, 500025
Contact: Dr. Nikhil Gharyalpatil    8008037474    nikhilghadyalpatil@gmail.com   
Dr. Nikhil's Clinic Recruiting
Secunderabad, Andhra Pradesh, India, 500025
Contact: Dr. Nikhil Ghadyalpatil    8008037474    nikhilghadyalpatil@gmail.com   
Ravi Kumar's Clinic Recruiting
Hyderabad, Andrapradesh, India, 500001
Contact: Dr. Ravi Kumar    91- 9949385000    drravikumar@gmail.com   
Ambaa Hospitals Recruiting
Hyderabad, Andrapradesh, India, 500008
Contact: Dr. S. S. Nirni    9849062003    nirni2002@rediffmail.com   
Swarna Sai Hospital Recruiting
Hyderabad, Andrapradesh, India, 500059
Contact: Dr. C. Sairam    9849032198    brcsairam@hotmail.com   
Manipal Centre For Clinical Research Recruiting
Mangalore, Bangalore, India, 575 001
Contact: Dr. Krishna Prasad    9880345666    drkrishnaprasad@hotmail.com   
Medical College Calicut Recruiting
Kerala, Calicut, India, 673016
Contact: Dr. Narayanankutty Warrier    91-495-2740995    n_goray@rediffmail.com   
Hemato Oncology Clinic Recruiting
Ahmedabad, Gujarat, India, 380009
Contact: Dr. Chirag Desai    91 -79 4004 2223    chiragdesai.oncology@gmail.com   
Kattimani Oncology Clinic Recruiting
Hubli, Karnataka, India, 580020
Contact: Dr. Kiran Kattimani    9480616656    dr_kattimani@yahoo.com   
SKIMS Recruiting
Srinagar, Kashmir, India, 190001
Contact: Dr. S. Aziz    9419415365    saejaz2000@yahoo.co.in   
S. K. I. M. S. Recruiting
Srinagar, Kashmir, India, 190010
Contact: Dr. Manzoor Ahmed Banday    9419019080    mutaibma@yahoo.com   
Dr. T. P. Sahoo's Clinic Recruiting
Bhopal, Madhya Pradesh, India, 462001
Contact: Dr. Tarini P Sahoo    9893686246    tarini73@rediffmail.com   
BND Onco Centre Recruiting
Mumbai, Maharashtra, India, 400014
Contact: Dr. Boman Dhabhar    91-9820344570    drboman@hotmail.com   
Joy Hospital Recruiting
Mumbai, Maharashtra, India, 400071
Contact: Dr. R. Gopal    91-9820192131    rgopal1@gmail.com   
Ruby Hall Clinic Recruiting
Pune, Maharashtra, India, 411001
Contact: Dr. Minish Jain    9823133390    minishjain009@gmail.com   
Grace Nursing Home Recruiting
Aizwal, Mizoram, India, 796 009
Contact: Dr. Jeremy Pautu    9436150301    jlpautu@gmail.com   
Lilavati Hospital Recruiting
Bandra, Mumbai, India, 400050
Contact: Dr. B. K. Smruti    91-9820222964    drsmruti2002@yahoo.co.in   
S.L.Raheja Hospital Recruiting
Mahim, Mumbai, India, 400016
Contact: Dr. S. H. Advani    022-24445526    shadvani2000@yahoo.com   
Rajiv Gandhi Cancer Institute & Research Recruiting
Delhi, New Delhi, India, 110085
Contact: Dr. Vineet Talwar    9810241512    drvineettalwar@yahoo.com   
Apollo Cancer Institute Recruiting
Delhi, New Delhi, India, 110044
Contact: Dr. K. P. Das    9810444600    drpratapdas@gmail.com   
Rajiv Gandhi Cancer Institute & Research Recruiting
Delhi, New Delhi, India, 110085
Contact: Dr. Vineet Talwar    9810241512    9810241512 drvineettalwar@yahoo.com   
Fortis Escorts Hospital Recruiting
Amritsar, Punjab, India, 143004
Contact: Dr. R. Gupta    9779949615    dr_rajeevgupta@rediffmail.com   
Dr. Rajeev Bedi's Clinic Recruiting
Chandigarh, Punjab, India, 160101
Contact: Dr. Rajeev Bedi    9542972901    rajeevbedi@yahoo.co.in   
D.M.C Hospital Recruiting
Ludhiana, Punjab, India, 141001
Contact: Dr. J. S. Sekhon    9815292928    jagdevsekhon@hotmail.com   
IVY Hospital Recruiting
Mohali, Punjab, India, 160071
Contact: Dr. Jatin Sarin    91-172-5044333    drjatin.s@yahoo.com   
Bhagwan Mahaveer Cancer Hospital & Research Centre Recruiting
Jaipur, Rajasthan, India, 302030
Contact: Dr. Lalit Sharma    99286 02244    drlalit2003@yahoo.com   
SMS Hospital Recruiting
Jaipur, Rajasthan, India, 302004
Contact: Dr. D. P. Singh    094142-63400    drdpsingh@yahoo.com   
Bhagwan Mahaveer Cancer Hospital Recruiting
Jaipur, Rajasthan, India, 302006
Contact: Dr. Naresh Somani    0141-2700107    drsomani@somexresearch.com   
Cancer Clinic Recruiting
Jaipur, Rajasthan, India, 302004
Contact: Dr. Sandeep Jasuja    9549099990    sandeep.jasuja@gmail.com   
Vyas Cancer Care Recruiting
Jodhpur, Rajasthan, India, 3420003
Contact: Dr. Vinay Vyas    9413063148    vinay25vyas@gmail.com   
TC 14/ 764 Sreemangalam Recruiting
Trivandrum, Tamilnadu, India, 695011
Contact: Dr. Jayaprakesh Madhavan    91-9447217437    jprakash.madhavan@gmail.com   
Shati Gopal Hospital Recruiting
Ghaziabad, Uttar Pradesh, India, 201014
Contact: Dr. Gopal Sharma    9717978967    drgopalsharma@yahoo.co.in   
Annapurna Medical and Cancer Relief Society Recruiting
Lucknow, Uttar Pradesh, India, 226007
Contact: Dr. Sanjeev Mishra    9919140407    drsanjeev.mishra@gmail.com   
Chittaranjan National Cancer Institute Recruiting
Kolkata, West Bengal, India, 700026
Contact: Dr. Jaydip Biswas    9830026696    drjbiswas.cnci@gmail.com   
Apollo Gleneagles Cancer Hospital Recruiting
Kolkata, West Bengal, India, 700054
Contact: Dr. P. N. Mohapatra    9674311610    prabrajya.mohapatra@rediffmail.com   
Nothern Railway Central Hospital Recruiting
Delhi, India, 110055
Contact: Dr. R. C. Joshi    9717630533    Joshi_rama@hotmail.com   
Indraprastha Apollo Hospital Recruiting
Delhi, India, 110076
Contact: Dr. Puneet Gupta    01126925858/5801    pgcancer@gmail.com   
Shanti Mukand Hospital Recruiting
Delhi, India, 110092
Contact: Dr. S. Khatri    9810381883    drsamkhatri@rediffmail.com   
Dharamshila Cancer Hospital & Research Centre Recruiting
Delhi, India, 110096
Contact: Dr. Praveen Kumar Bansal    9891707655    drpraveenkb@yahoo.com   
Indraprastha Apollo Hospital Recruiting
Delhi, India, 110076
Contact: Dr. Harsh Dua    9810056002    drharshdua@yahoo.co.in   
Sponsors and Collaborators
Merck KGaA
Merck Ltd., India
Investigators
Study Director: Rajiv Rana, MD Merck Ltd., India
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01134666     History of Changes
Other Study ID Numbers: EMR 062202-517
Study First Received: May 28, 2010
Last Updated: February 22, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by Merck KGaA:
Colorectal neoplasms
Intestinal neoplasms
Neoplasms
neoplasms
cetuximab
Erbitux

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014