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

Terminated

• Conditions: Carcinoma, Squamous Cell

• Registration Number: NCT01142869
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-31
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2013-07-31
• Study Completion: 2014-08-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.	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)

Secondary Outcome Measures

Name	Time	Method
To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.	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.

Trial Locations

Locations (28)

Ambaa Hospitals; 🇮🇳 Hyderabad, Andhra Pradesh, India

Indo- American Cancer Institute & Research Centre; 🇮🇳 Hyderabad, Andhra Pradesh, India

NVS Ramakrishna's Clinic; 🇮🇳 Hyderabad, Andhra Pradesh, India

Dr. Nikhil's Clinic; 🇮🇳 Secunderabad, Andhra Pradesh, India

Swarna Sai Hospital; 🇮🇳 Secunderabad, Andhra Pradesh, India

Sparsh Hospital; 🇮🇳 Orissa, Bhubaneswar, India

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India

Wellness Consultants Clinic; 🇮🇳 Surat, Gujarat, India

Global Health Pvt Ltd; 🇮🇳 Gurgaon, Haryana, India

The Cancer Clinic; 🇮🇳 Kochin, Kerala, India

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