Clinical trial NCT01134666: 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
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Neoplasms
Keywords: Colorectal neoplasms
Intestinal neoplasms
Neoplasms
cetuximab
Erbitux
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Ltd., India
First posted: 2010-06-02
Enrollment: 165
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with KRAS wild-type CRC receiving FOLFOX/FOLFIRI and cetuximab in India.

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.

Eligibility 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

Primary outcomes:
measure: Safety and tolerability evaluated based on the incidence and severity of AEs.
timeFrame: From baseline to follow-up visit for any ongoing AEs
Secondary outcomes:
measure: Response rate
timeFrame: Baseline to End-of-Study Visit
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Indo- American Cancer Institute & Research Centre
state: Andhra Pradesh
city: Hyderabad
country: India
facility: NVS Ramakrishna's Clinic
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Dr. Nikhil's Clinic
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Nikhil Gharyalpatil's Clinic
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Ravi Kumar's Clinic
state: Andrapradesh
city: Hyderabad
country: India
facility: Ambaa Hospitals
state: Andrapradesh
city: Hyderabad
country: India
facility: Swarna Sai Hospital
state: Andrapradesh
city: Mangalore
country: India
facility: Manipal Centre For Clinical Research
state: Bangalore
city: Kerala
country: India
facility: Medical College Calicut
state: Calicut
city: Ahmedabad
country: India
facility: Hemato Oncology Clinic
state: Gujarat
city: Hubli
country: India
facility: Kattimani Oncology Clinic
state: Karnataka
city: Srinagar
country: India
facility: SKIMS
state: Kashmir
city: Srinagar
country: India
facility: S. K. I. M. S.
state: Kashmir
city: Bhopal
country: India
facility: Dr. T. P. Sahoo's Clinic
state: Madhya Pradesh
city: Mumbai
country: India
facility: BND Onco Centre
state: Maharashtra
city: Mumbai
country: India
facility: Joy Hospital
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Aizwal
country: India
facility: Grace Nursing Home
state: Mizoram
city: Bandra
country: India
facility: Lilavati Hospital
state: Mumbai
city: Mahim
country: India
facility: S.L.Raheja Hospital
state: Mumbai
city: Delhi
country: India
facility: Apollo Cancer Institute
state: New Delhi
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research
state: New Delhi
city: Amritsar
country: India
facility: Fortis Escorts Hospital
state: Punjab
city: Chandigarh
country: India
facility: Dr. Rajeev Bedi's Clinic
state: Punjab
city: Ludhiana
country: India
facility: D.M.C Hospital
state: Punjab
city: Mohali
country: India
facility: IVY Hospital
state: Punjab
city: Jaipur
country: India
facility: Cancer Clinic
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital & Research Centre
state: Rajasthan
city: Jodhpur
country: India
facility: Vyas Cancer Care
state: Rajasthan
city: Trivandrum
country: India
facility: TC 14/ 764 Sreemangalam
state: Tamilnadu
city: Ghaziabad
country: India
facility: Shati Gopal Hospital
state: Uttar Pradesh
city: Lucknow
country: India
facility: Annapurna Medical and Cancer Relief Society
state: Uttar Pradesh
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute
state: West Bengal
city: Kolkata
country: India
facility: Apollo Gleneagles Cancer Hospital
state: West Bengal
city: Delhi
country: India
facility: Nothern Railway Central Hospital
city: Delhi
country: India
facility: Indraprastha Apollo Hospital
city: Delhi
country: India
facility: Shanti Mukand Hospital
city: Delhi
country: India
facility: Dharamshila Cancer Hospital & Research Centre
Study officials:
affiliation: Merck Ltd., India
name: Rajiv Rana, MD
role: STUDY_DIRECTOR
References: