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
NCT ID: NCT01134666
Last Updated: 2017-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
165 participants
OBSERVATIONAL
2009-11-30
2014-08-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Merck Ltd., India
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Rajiv Rana, MD
Role: STUDY_DIRECTOR
Merck Ltd., India
Locations
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Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, India
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, India
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, 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
Manipal Centre For Clinical Research
Mangalore, Bangalore, India
Medical College Calicut
Kerala, Calicut, India
Hemato Oncology Clinic
Ahmedabad, Gujarat, India
SKIMS
Srinagar, Jammu and Kashmir, India
S. K. I. M. S.
Srinagar, Jammu and Kashmir, India
Kattimani Oncology Clinic
Hubli, Karnataka, India
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, India
BND Onco Centre
Mumbai, Maharashtra, India
Joy Hospital
Mumbai, Maharashtra, India
Ruby Hall Clinic
Pune, Maharashtra, India
Grace Nursing Home
Aizawl, Mizoram, India
Lilavati Hospital
Bāndra, Mumbai, India
S.L.Raheja Hospital
Mahīm, Mumbai, India
Apollo Cancer Institute
Delhi, New Delhi, India
Rajiv Gandhi Cancer Institute & Research
Delhi, New Delhi, India
Fortis Escorts Hospital
Amritsar, Punjab, India
Dr. Rajeev Bedi's Clinic
Chandigarh, Punjab, India
D.M.C Hospital
Ludhiana, Punjab, India
IVY Hospital
Mohali, Punjab, India
Cancer Clinic
Jaipur, Rajasthan, India
SMS Hospital
Jaipur, Rajasthan, India
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, Rajasthan, India
Vyas Cancer Care
Jodhpur, Rajasthan, India
TC 14/ 764 Sreemangalam
Trivandrum, Tamil Nadu, 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
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, India
Nothern Railway Central Hospital
Delhi, , India
Indraprastha Apollo Hospital
Delhi, , India
Shanti Mukand Hospital
Delhi, , India
Dharamshila Cancer Hospital & Research Centre
Delhi, , India
Countries
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Other Identifiers
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EMR 062202-517
Identifier Type: -
Identifier Source: org_study_id
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