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
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 165
- 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)
- 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)
D.M.C Hospital
🇮🇳Ludhiana, Punjab, India
S.L.Raheja Hospital
🇮🇳Mahim, Mumbai, India
Apollo Cancer Institute
🇮🇳Delhi, New Delhi, India
Fortis Escorts Hospital
🇮🇳Amritsar, Punjab, India
SMS Hospital
🇮🇳Jaipur, Rajasthan, India
Cancer Clinic
🇮🇳Jaipur, Rajasthan, India
Nothern Railway Central Hospital
🇮🇳Delhi, India
Dr. Nikhil's Clinic
🇮🇳Secunderabad, Andhra Pradesh, India
Grace Nursing Home
🇮🇳Aizwal, Mizoram, India
BND Onco Centre
🇮🇳Mumbai, Maharashtra, India
NVS Ramakrishna's Clinic
🇮🇳Hyderabad, Andhra Pradesh, India
Manipal Centre For Clinical Research
🇮🇳Mangalore, Bangalore, India
SKIMS
🇮🇳Srinagar, Kashmir, India
S. K. I. M. S.
🇮🇳Srinagar, Kashmir, India
Hemato Oncology Clinic
🇮🇳Ahmedabad, Gujarat, India
Joy Hospital
🇮🇳Mumbai, Maharashtra, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
🇮🇳Jaipur, Rajasthan, India
Lilavati Hospital
🇮🇳Bandra, Mumbai, India
Indo- American Cancer Institute & Research Centre
🇮🇳Hyderabad, Andhra Pradesh, India
Dr. Rajeev Bedi's Clinic
🇮🇳Chandigarh, Punjab, India
Shanti Mukand Hospital
🇮🇳Delhi, India
Dharamshila Cancer Hospital & Research Centre
🇮🇳Delhi, India
Dr. T. P. Sahoo's Clinic
🇮🇳Bhopal, Madhya Pradesh, India
Vyas Cancer Care
🇮🇳Jodhpur, Rajasthan, India
Apollo Gleneagles Cancer Hospital
🇮🇳Kolkata, West Bengal, 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
Medical College Calicut
🇮🇳Kerala, Calicut, India
Kattimani Oncology Clinic
🇮🇳Hubli, Karnataka, India
Rajiv Gandhi Cancer Institute & Research
🇮🇳Delhi, New Delhi, India
TC 14/ 764 Sreemangalam
🇮🇳Trivandrum, Tamilnadu, India
Indraprastha Apollo Hospital
🇮🇳Delhi, India
IVY Hospital
🇮🇳Mohali, Punjab, India
Bhagwan Mahaveer Cancer Hospital
🇮🇳Jaipur, Rajasthan, India
Shati Gopal Hospital
🇮🇳Ghaziabad, Uttar Pradesh, India
Annapurna Medical and Cancer Relief Society
🇮🇳Lucknow, Uttar Pradesh, India
Chittaranjan National Cancer Institute
🇮🇳Kolkata, West Bengal, India
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India