Clinical trial NCT01142869: 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
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carcinoma, Squamous Cell
Keywords: Carcinoma, Squamous Cell
Erbitux
Neoplasms, Squamous Cell
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Ltd., India
First posted: 2010-06-11
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with squamous cell carcinoma of head and neck

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.


Eligibility 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

Primary outcomes:
measure: To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
timeFrame: From first infusion of cetuximab until 28 days after the last infusion.
Secondary outcomes:
measure: To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.
timeFrame: From first infusion of cetuximab until 28 days after the last infusion.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Ambaa Hospitals
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Indo- American Cancer Institute & Research Centre
state: Andhra Pradesh
city: Hyderabad
country: India
facility: NVS Ramakrishna's Clinic
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Dr. Nikhil's Clinic
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Swarna Sai Hospital
state: Andhra Pradesh
city: Orissa
country: India
facility: Sparsh Hospital
state: Bhubaneswar
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: Surat
country: India
facility: Wellness Consultants Clinic
state: Gujarat
city: Gurgaon
country: India
facility: Global Health Pvt Ltd
state: Haryana
city: Kochin
country: India
facility: The Cancer Clinic
state: Kerala
city: Bhopal
country: India
facility: Dr. T. P. Sahoo's Clinic
state: Madhya Pradesh
city: Mumbai
country: India
facility: BND Onco Centre
state: Maharashtra
city: Mumbai
country: India
facility: S.L.Raheja Hospital
state: Maharashtra
city: Pune
country: India
facility: S M Karandikar's Clinic
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Galaxy Care Laproscopic Institute
state: Maharashtra
city: Shillong
country: India
facility: Neigrihms
state: Meghalaya
city: Aizwal
country: India
facility: Grace Nursing Home
state: Mizoram
city: Jaipur
country: India
facility: Cancer Clinic
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital
state: Rajasthan
city: Kanpur
country: India
facility: J.K.Cancer Institute
state: Uttar Pradesh
city: Lucknow
country: India
facility: Annapurna Medical and Cancer Relief Society
state: Uttar Pradesh
city: New Delhi
country: India
facility: Dr. Vineet's Clinic
state: Uttar Pradesh
city: New Delhi
country: India
facility: SMH-Curie Cancer Centre, Shanti Mukand Hospital
state: Uttar Pradesh
city: Kolkata
country: India
facility: Apollo Gleneagles Cancer Hospital
state: West Bengal
city: Kolkatta
country: India
facility: B.R. Singh Hospital
state: West Bengal
city: Delhi
country: India
facility: Sunil Gupta's Clinic
Study officials:
affiliation: Merck Ltd., India
name: Dr. Rajiv Rana
role: STUDY_DIRECTOR
References: