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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 has been terminated.
(The study was discontinued due to slow recruitment and subjects not completing follow up period.)
Sponsor:
Collaborator:
Merck Ltd., India
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01134666
First received: May 28, 2010
Last updated: November 7, 2014
Last verified: November 2014
  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


Enrollment: 165
Study Start Date: November 2009
Estimated Study Completion Date: April 2017
Primary Completion Date: July 2013 (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
Hyderabad, Andhra Pradesh, India, 500034
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, India, 500063
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, India, 500025
Nikhil Gharyalpatil's Clinic
Secunderabad, Andhra Pradesh, India, 500025
Ambaa Hospitals
Hyderabad, Andrapradesh, India, 500008
Ravi Kumar's Clinic
Hyderabad, Andrapradesh, India, 500001
Swarna Sai Hospital
Hyderabad, Andrapradesh, India, 500059
Manipal Centre For Clinical Research
Mangalore, Bangalore, India, 575 001
Medical College Calicut
Kerala, Calicut, India, 673016
Hemato Oncology Clinic
Ahmedabad, Gujarat, India, 380009
Kattimani Oncology Clinic
Hubli, Karnataka, India, 580020
S. K. I. M. S.
Srinagar, Kashmir, India, 190010
SKIMS
Srinagar, Kashmir, India, 190001
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, India, 462001
BND Onco Centre
Mumbai, Maharashtra, India, 400014
Joy Hospital
Mumbai, Maharashtra, India, 400071
Ruby Hall Clinic
Pune, Maharashtra, India, 411001
Grace Nursing Home
Aizwal, Mizoram, India, 796 009
Lilavati Hospital
Bandra, Mumbai, India, 400050
S.L.Raheja Hospital
Mahim, Mumbai, India, 400016
Apollo Cancer Institute
Delhi, New Delhi, India, 110044
Rajiv Gandhi Cancer Institute & Research
Delhi, New Delhi, India, 110085
Fortis Escorts Hospital
Amritsar, Punjab, India, 143004
Dr. Rajeev Bedi's Clinic
Chandigarh, Punjab, India, 160101
D.M.C Hospital
Ludhiana, Punjab, India, 141001
IVY Hospital
Mohali, Punjab, India, 160071
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, India, 302006
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, Rajasthan, India, 302030
Cancer Clinic
Jaipur, Rajasthan, India, 302004
SMS Hospital
Jaipur, Rajasthan, India, 302004
Vyas Cancer Care
Jodhpur, Rajasthan, India, 3420003
TC 14/ 764 Sreemangalam
Trivandrum, Tamilnadu, India, 695011
Shati Gopal Hospital
Ghaziabad, Uttar Pradesh, India, 201014
Annapurna Medical and Cancer Relief Society
Lucknow, Uttar Pradesh, India, 226007
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, India, 700054
Chittaranjan National Cancer Institute
Kolkata, West Bengal, India, 700026
Dharamshila Cancer Hospital & Research Centre
Delhi, India, 110096
Indraprastha Apollo Hospital
Delhi, India, 110076
Nothern Railway Central Hospital
Delhi, India, 110055
Shanti Mukand Hospital
Delhi, India, 110092
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: November 7, 2014
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
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014