- ICH GCP
- US Clinical Trials Registry
- 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
May 4, 2017 updated by: Merck KGaA, Darmstadt, Germany
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
133
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delhi, India, 110092
- Sunil Gupta's Clinic
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500008
- Ambaa Hospitals
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Hyderabad, Andhra Pradesh, India, 500034
- Indo- American Cancer Institute & Research Centre
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Hyderabad, Andhra Pradesh, India, 500063
- NVS Ramakrishna's Clinic
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Secunderabad, Andhra Pradesh, India, 500025
- Dr. Nikhil's Clinic
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Secunderabad, Andhra Pradesh, India, 500059
- Swarna Sai Hospital
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Bhubaneswar
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Orissa, Bhubaneswar, India, 751007
- Sparsh Hospital
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Delhi
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New Delhi, Delhi, India, 110029
- All India Institute of Medical Sciences
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Gujarat
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Surat, Gujarat, India, 395002
- Wellness Consultants Clinic
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Haryana
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Gurgaon, Haryana, India, 122001
- Global Health Pvt Ltd
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Kerala
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Kochin, Kerala, India, 682304
- The Cancer Clinic
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India, 462001
- Dr. T. P. Sahoo's Clinic
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Maharashtra
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Mumbai, Maharashtra, India, 400014
- BND Onco Centre
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Mumbai, Maharashtra, India, 400016
- S.L.Raheja Hospital
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Pune, Maharashtra, India, 411001
- Ruby Hall Clinic
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Pune, Maharashtra, India, 400014
- S M Karandikar's Clinic
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Pune, Maharashtra, India, 411004
- Galaxy Care Laproscopic Institute
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Meghalaya
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Shillong, Meghalaya, India, 793005
- Neigrihms
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Mizoram
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Aizwal, Mizoram, India, 796 009
- Grace Nursing Home
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Rajasthan
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Jaipur, Rajasthan, India, 302004
- SMS Hospital
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Jaipur, Rajasthan, India, 302004
- Cancer Clinic
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Jaipur, Rajasthan, India, 302006
- Bhagwan Mahaveer Cancer Hospital
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Uttar Pradesh
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Kanpur, Uttar Pradesh, India, 208002
- J.K.Cancer Institute
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Lucknow, Uttar Pradesh, India, 226007
- Annapurna Medical and Cancer Relief Society
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New Delhi, Uttar Pradesh, India, 110085
- Dr. Vineet's Clinic
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New Delhi, Uttar Pradesh, India, 110092
- SMH-Curie Cancer Centre, Shanti Mukand Hospital
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West Bengal
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Kolkata, West Bengal, India, 700054
- Apollo Gleneagles Cancer Hospital
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Kolkatta, West Bengal, India, 700014
- B.R. Singh Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with squamous cell carcinoma of head and neck
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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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From first infusion of cetuximab until 28 days after the last infusion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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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From first infusion of cetuximab until 28 days after the last infusion.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Dr. Rajiv Rana, Merck Ltd., India
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 31, 2009
Primary Completion (Actual)
July 31, 2013
Study Completion (Actual)
August 5, 2014
Study Registration Dates
First Submitted
June 10, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimate)
June 11, 2010
Study Record Updates
Last Update Posted (Actual)
May 8, 2017
Last Update Submitted That Met QC Criteria
May 4, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR 062202-514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage... and other conditionsCanada, United States
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Caregiver | Salivary Gland Squamous Cell Carcinoma | Malignant Head and Neck Neoplasm | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Stage... and other conditionsUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
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NRG OncologyNational Cancer Institute (NCI)RecruitingAdvanced Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of Unknown Primary | Advanced Hypopharyngeal Squamous Cell Carcinoma | Advanced Laryngeal Squamous Cell Carcinoma | Advanced Oropharyngeal Squamous Cell CarcinomaUnited States, Canada
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-
UNC Lineberger Comprehensive Cancer CenterMayo Clinic; National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCarcinoma, Squamous Cell | Head and Neck Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | Oropharynx Squamous Cell CarcinomaUnited States
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West China HospitalFirst Affiliated Hospital of Chongqing Medical UniversityRecruitingColo-rectal Cancer | Capecitabine | CetuximabChina
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Amsterdam UMC, location VUmcRadboud University Medical Center; University Medical Center GroningenTerminatedMetastatic Colorectal CancerNetherlands
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Eben RosenthalNational Cancer Institute (NCI)TerminatedPancreatic AdenocarcinomaUnited States
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HiberCell, Inc.TerminatedColorectal CancerUnited States, Puerto Rico, Germany, France
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Merck KGaA, Darmstadt, GermanyCompletedPreviously Untreated Metastatic Colorectal CancerFrance, Italy, Poland, Germany, Hong Kong, Austria, Brazil, Israel, Greece, Argentina, Thailand, Belgium, Australia, Mexico
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Arbeitsgemeinschaft medikamentoese TumortherapieMerck Sharp & Dohme LLCCompleted
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Cancer Institute and Hospital, Chinese Academy...Recruiting
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Poitiers University HospitalCompletedMetastatic Colon CancerFrance
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Cliniques universitaires Saint-Luc- Université...Merck Sharp & Dohme LLC; Merck Serono International SACompleted