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

Carcinoma, Squamous Cell Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01142869
• Other study ID #: EMR 062202-514
• Status: Terminated
• Phase: N/A
• First received: June 10, 2010
• Last updated: May 4, 2017
• Start date: December 31, 2009
• Est. completion date: August 5, 2014

Study information

• Verified date: May 2017
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: August 5, 2014
• Est. primary completion date: July 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
India	Grace Nursing Home	Aizwal	Mizoram
India	Dr. T. P. Sahoo's Clinic	Bhopal	Madhya Pradesh
India	Sunil Gupta's Clinic	Delhi
India	Global Health Pvt Ltd	Gurgaon	Haryana
India	Ambaa Hospitals	Hyderabad	Andhra Pradesh
India	Indo- American Cancer Institute & Research Centre	Hyderabad	Andhra Pradesh
India	NVS Ramakrishna's Clinic	Hyderabad	Andhra Pradesh
India	Bhagwan Mahaveer Cancer Hospital	Jaipur	Rajasthan
India	Cancer Clinic	Jaipur	Rajasthan
India	SMS Hospital	Jaipur	Rajasthan
India	J.K.Cancer Institute	Kanpur	Uttar Pradesh
India	The Cancer Clinic	Kochin	Kerala
India	Apollo Gleneagles Cancer Hospital	Kolkata	West Bengal
India	B.R. Singh Hospital	Kolkatta	West Bengal
India	Annapurna Medical and Cancer Relief Society	Lucknow	Uttar Pradesh
India	BND Onco Centre	Mumbai	Maharashtra
India	S.L.Raheja Hospital	Mumbai	Maharashtra
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Dr. Vineet's Clinic	New Delhi	Uttar Pradesh
India	SMH-Curie Cancer Centre, Shanti Mukand Hospital	New Delhi	Uttar Pradesh
India	Sparsh Hospital	Orissa	Bhubaneswar
India	Galaxy Care Laproscopic Institute	Pune	Maharashtra
India	Ruby Hall Clinic	Pune	Maharashtra
India	S M Karandikar's Clinic	Pune	Maharashtra
India	Dr. Nikhil's Clinic	Secunderabad	Andhra Pradesh
India	Swarna Sai Hospital	Secunderabad	Andhra Pradesh
India	Neigrihms	Shillong	Meghalaya
India	Wellness Consultants Clinic	Surat	Gujarat

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Ltd., India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.	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	To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.	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.