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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 has been terminated.
(The study was discontinued due to slow recruitment and subjects not completing follow up period.)
Sponsor:
Collaborator:
Merck Ltd., India
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01142869
First received: June 10, 2010
Last updated: November 7, 2014
Last verified: November 2014
  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


Enrollment: 133
Study Start Date: December 2009
Estimated Study Completion Date: April 2016
Primary Completion Date: July 2013 (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
Ambaa Hospitals
Hyderabad, Andhra Pradesh, India, 500008
Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, India, 500034
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, India, 500063
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, India, 500025
Swarna Sai Hospital
Secunderabad, Andhra Pradesh, India, 500059
Sparsh Hospital
Orissa, Bhubaneswar, India, 751007
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Wellness Consultants Clinic
Surat, Gujarat, India, 395002
Global Health Pvt Ltd
Gurgaon, Haryana, India, 122001
The Cancer Clinic
Kochin, Kerala, India, 682304
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, India, 462001
BND Onco Centre
Mumbai, Maharashtra, India, 400014
S.L.Raheja Hospital
Mumbai, Maharashtra, India, 400016
Galaxy Care Laproscopic Institute
Pune, Maharashtra, India, 411004
Ruby Hall Clinic
Pune, Maharashtra, India, 411001
S M Karandikar's Clinic
Pune, Maharashtra, India, 400014
Neigrihms
Shillong, Meghalaya, India, 793005
Grace Nursing Home
Aizwal, Mizoram, India, 796 009
SMS Hospital
Jaipur, Rajasthan, India, 302004
Cancer Clinic
Jaipur, Rajasthan, India, 302004
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, India, 302006
J.K.Cancer Institute
Kanpur, Uttar Pradesh, India, 208002
Annapurna Medical and Cancer Relief Society
Lucknow, Uttar Pradesh, India, 226007
Dr. Vineet's Clinic
New Delhi, Uttar Pradesh, India, 110085
SMH-Curie Cancer Centre, Shanti Mukand Hospital
New Delhi, Uttar Pradesh, India, 110092
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, India, 700054
B.R. Singh Hospital
Kolkatta, West Bengal, India, 700014
Sunil Gupta's Clinic
Delhi, India, 110092
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: November 7, 2014
Health Authority: India: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 24, 2014