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 is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Ltd., India
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01142869
First received: June 10, 2010
Last updated: February 22, 2013
Last verified: February 2013

June 10, 2010
February 22, 2013
December 2009
September 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01142869 on ClinicalTrials.gov Archive Site
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.
Same as current
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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
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)

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Whole Blood

Non-Probability Sample

Patients with squamous cell carcinoma of head and neck

Carcinoma, Squamous Cell
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2016
September 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
India
 
NCT01142869
EMR 062202-514
Not Provided
Merck KGaA
Merck KGaA
Merck Ltd., India
Study Director: Dr. Rajiv Rana Merck Ltd., India
Merck KGaA
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP