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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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Squamous Cell

Intervention: Cetuximab (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Dr. Rajiv Rana, Study Director, Affiliation: Merck Ltd., India

Summary

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.

Clinical Details

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)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.

Secondary outcome: To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Sunil Gupta's Clinic, Delhi 110092, India

Ambaa Hospitals, Hyderabad, Andhra Pradesh 500008, India

Indo- American Cancer Institute & Research Centre, Hyderabad, Andhra Pradesh 500034, India

NVS Ramakrishna's Clinic, Hyderabad, Andhra Pradesh 500063, India

Dr. Nikhil's Clinic, Secunderabad, Andhra Pradesh 500025, India

Swarna Sai Hospital, Secunderabad, Andhra Pradesh 500059, India

Sparsh Hospital, Orissa, Bhubaneswar 751007, India

All India Institute of Medical Sciences, New Delhi, Delhi 110029, India

Wellness Consultants Clinic, Surat, Gujarat 395002, India

Global Health Pvt Ltd, Gurgaon, Haryana 122001, India

The Cancer Clinic, Kochin, Kerala 682304, India

Dr. T. P. Sahoo's Clinic, Bhopal, Madhya Pradesh 462001, India

BND Onco Centre, Mumbai, Maharashtra 400014, India

S.L.Raheja Hospital, Mumbai, Maharashtra 400016, India

Galaxy Care Laproscopic Institute, Pune, Maharashtra 411004, India

Ruby Hall Clinic, Pune, Maharashtra 411001, India

S M Karandikar's Clinic, Pune, Maharashtra 400014, India

Neigrihms, Shillong, Meghalaya 793005, India

Grace Nursing Home, Aizwal, Mizoram 796 009, India

Bhagwan Mahaveer Cancer Hospital, Jaipur, Rajasthan 302006, India

Cancer Clinic, Jaipur, Rajasthan 302004, India

SMS Hospital, Jaipur, Rajasthan 302004, India

J.K.Cancer Institute, Kanpur, Uttar Pradesh 208002, India

Annapurna Medical and Cancer Relief Society, Lucknow, Uttar Pradesh 226007, India

Dr. Vineet's Clinic, New Delhi, Uttar Pradesh 110085, India

SMH-Curie Cancer Centre, Shanti Mukand Hospital, New Delhi, Uttar Pradesh 110092, India

Apollo Gleneagles Cancer Hospital, Kolkata, West Bengal 700054, India

B.R. Singh Hospital, Kolkatta, West Bengal 700014, India

Additional Information

Starting date: December 2009
Last updated: November 7, 2014

Page last updated: August 20, 2015

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