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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01134666
• Other study ID #: EMR 062202-517
• Status: Terminated
• Phase: N/A
• First received: May 28, 2010
• Last updated: June 8, 2017
• Start date: November 30, 2009
• Est. completion date: August 5, 2014

Study information

• Verified date: June 2017
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 165
• Est. completion date: August 5, 2014
• Est. primary completion date: July 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
India	Hemato Oncology Clinic	Ahmedabad	Gujarat
India	Grace Nursing Home	Aizwal	Mizoram
India	Fortis Escorts Hospital	Amritsar	Punjab
India	Lilavati Hospital	Bandra	Mumbai
India	Dr. T. P. Sahoo's Clinic	Bhopal	Madhya Pradesh
India	Dr. Rajeev Bedi's Clinic	Chandigarh	Punjab
India	Apollo Cancer Institute	Delhi	New Delhi
India	Dharamshila Cancer Hospital & Research Centre	Delhi
India	Indraprastha Apollo Hospital	Delhi
India	Nothern Railway Central Hospital	Delhi
India	Rajiv Gandhi Cancer Institute & Research	Delhi	New Delhi
India	Shanti Mukand Hospital	Delhi
India	Shati Gopal Hospital	Ghaziabad	Uttar Pradesh
India	Kattimani Oncology Clinic	Hubli	Karnataka
India	Ambaa Hospitals	Hyderabad	Andrapradesh
India	Indo- American Cancer Institute & Research Centre	Hyderabad	Andhra Pradesh
India	NVS Ramakrishna's Clinic	Hyderabad	Andhra Pradesh
India	Ravi Kumar's Clinic	Hyderabad	Andrapradesh
India	Swarna Sai Hospital	Hyderabad	Andrapradesh
India	Bhagwan Mahaveer Cancer Hospital	Jaipur	Rajasthan
India	Bhagwan Mahaveer Cancer Hospital & Research Centre	Jaipur	Rajasthan
India	Cancer Clinic	Jaipur	Rajasthan
India	SMS Hospital	Jaipur	Rajasthan
India	Vyas Cancer Care	Jodhpur	Rajasthan
India	Medical College Calicut	Kerala	Calicut
India	Apollo Gleneagles Cancer Hospital	Kolkata	West Bengal
India	Chittaranjan National Cancer Institute	Kolkata	West Bengal
India	Annapurna Medical and Cancer Relief Society	Lucknow	Uttar Pradesh
India	D.M.C Hospital	Ludhiana	Punjab
India	S.L.Raheja Hospital	Mahim	Mumbai
India	Manipal Centre For Clinical Research	Mangalore	Bangalore
India	IVY Hospital	Mohali	Punjab
India	BND Onco Centre	Mumbai	Maharashtra
India	Joy Hospital	Mumbai	Maharashtra
India	Ruby Hall Clinic	Pune	Maharashtra
India	Dr. Nikhil's Clinic	Secunderabad	Andhra Pradesh
India	Nikhil Gharyalpatil's Clinic	Secunderabad	Andhra Pradesh
India	S. K. I. M. S.	Srinagar	Kashmir
India	SKIMS	Srinagar	Kashmir
India	TC 14/ 764 Sreemangalam	Trivandrum	Tamilnadu

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Ltd., India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability evaluated based on the incidence and severity of AEs.		From baseline to follow-up visit for any ongoing AEs
Secondary	Response rate	Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)	Baseline to End-of-Study Visit