An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy in the First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck

May 4, 2017 updated by: Merck KGaA, Darmstadt, Germany

An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.

Study Overview

Status

Terminated

Conditions

Carcinoma, Squamous Cell

Intervention / Treatment

Drug: Cetuximab

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

India
- - Delhi, India, 110092
    - Sunil Gupta's Clinic
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500008
    - Ambaa Hospitals
  - Hyderabad, Andhra Pradesh, India, 500034
    - Indo- American Cancer Institute & Research Centre
  - Hyderabad, Andhra Pradesh, India, 500063
    - NVS Ramakrishna's Clinic
  - Secunderabad, Andhra Pradesh, India, 500025
    - Dr. Nikhil's Clinic
  - Secunderabad, Andhra Pradesh, India, 500059
    - Swarna Sai Hospital
- Bhubaneswar
  - Orissa, Bhubaneswar, India, 751007
    - Sparsh Hospital
- Delhi
  - New Delhi, Delhi, India, 110029
    - All India Institute of Medical Sciences
- Gujarat
  - Surat, Gujarat, India, 395002
    - Wellness Consultants Clinic
- Haryana
  - Gurgaon, Haryana, India, 122001
    - Global Health Pvt Ltd
- Kerala
  - Kochin, Kerala, India, 682304
    - The Cancer Clinic
- Madhya Pradesh
  - Bhopal, Madhya Pradesh, India, 462001
    - Dr. T. P. Sahoo's Clinic
- Maharashtra
  - Mumbai, Maharashtra, India, 400014
    - BND Onco Centre
  - Mumbai, Maharashtra, India, 400016
    - S.L.Raheja Hospital
  - Pune, Maharashtra, India, 411001
    - Ruby Hall Clinic
  - Pune, Maharashtra, India, 400014
    - S M Karandikar's Clinic
  - Pune, Maharashtra, India, 411004
    - Galaxy Care Laproscopic Institute
- Meghalaya
  - Shillong, Meghalaya, India, 793005
    - Neigrihms
- Mizoram
  - Aizwal, Mizoram, India, 796 009
    - Grace Nursing Home
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - SMS Hospital
  - Jaipur, Rajasthan, India, 302004
    - Cancer Clinic
  - Jaipur, Rajasthan, India, 302006
    - Bhagwan Mahaveer Cancer Hospital
- Uttar Pradesh
  - Kanpur, Uttar Pradesh, India, 208002
    - J.K.Cancer Institute
  - Lucknow, Uttar Pradesh, India, 226007
    - Annapurna Medical and Cancer Relief Society
  - New Delhi, Uttar Pradesh, India, 110085
    - Dr. Vineet's Clinic
  - New Delhi, Uttar Pradesh, India, 110092
    - SMH-Curie Cancer Centre, Shanti Mukand Hospital
- West Bengal
  - Kolkata, West Bengal, India, 700054
    - Apollo Gleneagles Cancer Hospital
  - Kolkatta, West Bengal, India, 700014
    - B.R. Singh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with squamous cell carcinoma of head and neck

Description

Inclusion Criteria:

The study inclusion criteria is as per the label for patients with metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease."
For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.

Exclusion Criteria:

Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria [NCI-CTC]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN. Time Frame: From first infusion of cetuximab until 28 days after the last infusion.	Safety variables will include the assessment of incidence and type of adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), incidence of withdrawals due to intolerability of cetuximab and severity of adverse events (AEs)	From first infusion of cetuximab until 28 days after the last infusion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN. Time Frame: From first infusion of cetuximab until 28 days after the last infusion.	Clinical efficacy will be assessed by best tumor response, disease control rate, progression-free survival and overall survival with cetuximab treatment.	From first infusion of cetuximab until 28 days after the last infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Ltd., India

Investigators

Study Director: Dr. Rajiv Rana, Merck Ltd., India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2009

Primary Completion (Actual)

July 31, 2013

Study Completion (Actual)

August 5, 2014

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria