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.
Verified February 2013 by Merck KGaA
Sponsor:
Merck KGaA
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
| Tracking Information | |||||
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| First Received Date ICMJE | June 10, 2010 | ||||
| Last Updated Date | February 22, 2013 | ||||
| Start Date ICMJE | December 2009 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01142869 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 ICMJE | 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) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Whole Blood |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with squamous cell carcinoma of head and neck |
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| Condition ICMJE | Carcinoma, Squamous Cell | ||||
| Intervention ICMJE | 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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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | April 2016 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01142869 | ||||
| Other Study ID Numbers ICMJE | EMR 062202-514 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Merck KGaA | ||||
| Study Sponsor ICMJE | Merck KGaA | ||||
| Collaborators ICMJE | Merck Ltd., India | ||||
| Investigators ICMJE |
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| Information Provided By | Merck KGaA | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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