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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Ltd., India
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01142869
First received: June 10, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Carcinoma, Squamous Cell
Drug: Cetuximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Clinical efficacy will be assessed by best tumor response, disease control rate, progression-free survival and overall survival with cetuximab treatment.


Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    The starting dose will be intravenous (IV) cetuximab 400 mg/m2 body surface area administered as a 120-minute infusion once a week . The subsequent weekly doses will be IV cetuximab 250 mg/m2 administered as a 60-minute infusion. The maximum infusion rate must not exceed 10 mg/min.
    Other Name: Erbitux
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with squamous cell carcinoma of head and neck

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142869

Locations
India
Indo- American Cancer Institute & Research Centre Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Dr. Palanki S. Dattatreya    91-9440591396    satya_palanki@rediffmail.com   
NVS Ramakrishna's Clinic Recruiting
Hyderabad, Andhra Pradesh, India, 500063
Contact: Dr. N V S. Ramkrishna    9949341112    rnalla@gmail.com   
Ambaa Hospitals Recruiting
Hyderabad, Andhra Pradesh, India, 500008
Contact: Dr. S. S. Nirni    9849062003    nirni2002@rediffmail.com   
Swarna Sai Hospital Recruiting
Secunderabad, Andhra Pradesh, India, 500059
Contact: Dr. C. Sairam    9849032198    brcsairam@hotmail.com   
Dr. Nikhil's Clinic Recruiting
Secunderabad, Andhra Pradesh, India, 500025
Contact: Dr. Nikhil Ghadyalpatil    8008037474    nikhilghadyalpatil@gmail.com   
Sparsh Hospital Recruiting
Orissa, Bhubaneswar, India, 751007
Contact: Dr. Ghanashyam Biswas    9937500878    drgbiswas@yahoo.com   
All India Institute of Medical Sciences Recruiting
New Delhi, Delhi, India, 110029
Contact: Dr. Atul Sharma    9818548149    atul1@hotmail.com   
Wellness Consultants Clinic Recruiting
Surat, Gujarat, India, 395002
Contact: Dr. Tanveer Maksud    9909918887    tanveermaksud@yahoo.com   
Global Health Pvt Ltd Recruiting
Gurgaon, Haryana, India, 122001
Contact: Dr. Ashok Vaid    9810212235    akvaid@yahoo.com   
The Cancer Clinic Recruiting
Kochin, Kerala, India, 682304
Contact: Dr. Thomas Varughese    9447173088    drthomas.surgoncologist@gmail.com   
Dr. T. P. Sahoo's Clinic Recruiting
Bhopal, Madhya Pradesh, India, 462001
Contact: Dr. Tarini P Sahoo    9893686246    tarini73@rediffmail.com   
BND Onco Centre Recruiting
Mumbai, Maharashtra, India, 400014
Contact: Dr. Boman Dhabhar    9820344570    drboman@hotmail.com   
S.L.Raheja Hospital Recruiting
Mumbai, Maharashtra, India, 400016
Contact: Dr. S. H. Advani    022-24445526    shadvani2000@yahoo.com   
Galaxy Care Laproscopic Institute Recruiting
Pune, Maharashtra, India, 411004
Contact: Dr. S Puntambekar Puntambekar    9822023706    shase63@gmail.com   
Ruby Hall Clinic Recruiting
Pune, Maharashtra, India, 411001
Contact: Dr. Minish Jain    9823133390    minishjain009@gmail.com   
S M Karandikar's Clinic Recruiting
Pune, Maharashtra, India, 400014
Contact: Dr. S M Karandikar    9890281963    skaran44@gmail.com   
Neigrihms Recruiting
Shillong, Meghalaya, India, 793005
Contact: Dr. Dillip Kumar Parida    94361-14334    dkparida@hotmail.com   
Grace Nursing Home Recruiting
Aizwal, Mizoram, India, 796 009
Contact: Dr. Jeremy Pautu    9436150301    jlpautu@gmail.com   
SMS Hospital Recruiting
Jaipur, Rajasthan, India, 302004
Contact: Dr. D. P. Singh    094142-63400    drdpsingh@yahoo.com   
Cancer Clinic Recruiting
Jaipur, Rajasthan, India, 302004
Contact: Dr. Sandeep Jasuja    9549099990    sandeep.jasuja@gmail.com   
Bhagwan Mahaveer Cancer Hospital Recruiting
Jaipur, Rajasthan, India, 302006
Contact: Dr. Naresh Somani    0141-2700107    drsomani@somexresearch.com   
J.K.Cancer Institute Recruiting
Kanpur, Uttar Pradesh, India, 208002
Contact: Dr. Sharad Singh    9452062985    sharad_onco@yahoo.co.in   
Annapurna Medical and Cancer Relief Society Recruiting
Lucknow, Uttar Pradesh, India, 226007
Contact: Dr. Sanjeev Mishra    9919140407    drsanjeev.mishra@gmail.com   
Dr. Vineet's Clinic Recruiting
New Delhi, Uttar Pradesh, India, 110085
Contact: Dr. Vineet Talwar    9810241512    drvineettalwar@yahoo.com   
SMH-Curie Cancer Centre, Shanti Mukand Hospital Recruiting
New Delhi, Uttar Pradesh, India, 110092
Contact: Dr. Sameer Khatri    9810381883    drsamkhatri@rediffmail.com   
Apollo Gleneagles Cancer Hospital Recruiting
Kolkata, West Bengal, India, 700054
Contact: Dr. P. N. Mohapatra    9674311610    prabrajya.mohapatra@rediffmail.com   
B.R. Singh Hospital Recruiting
Kolkatta, West Bengal, India, 700014
Contact: Dr. Madhuchanda Kar    9830155915    madhuchandakar@yahoo.com   
Sunil Gupta's Clinic Recruiting
Delhi, India, 110092
Contact: Dr. Sunil Kumar Gupta    9811102971    drsgonco@rediffmail.com   
Sponsors and Collaborators
Merck KGaA
Merck Ltd., India
Investigators
Study Director: Dr. Rajiv Rana Merck Ltd., India
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01142869     History of Changes
Other Study ID Numbers: EMR 062202-514
Study First Received: June 10, 2010
Last Updated: February 22, 2013
Health Authority: India: Ministry of Health

Keywords provided by Merck KGaA:
Carcinoma, Squamous Cell
Erbitux
Neoplasms, Squamous Cell

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014