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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Carcinoma, Squamous Cell |
Drug: Cetuximab |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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) |
Resource links provided by NLM:
Further study details as provided by Merck KGaA:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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.
Biospecimen Retention: Samples With DNA
Whole Blood
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with squamous cell carcinoma of head and neck
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142869
Locations
| India | |
| Ambaa Hospitals | Recruiting |
| Hyderabad, Andhra Pradesh, India, 500008 | |
| Contact: Dr. S. S. Nirni 9849062003 nirni2002@rediffmail.com | |
| Indo- American Cancer Institute & Research Centre | Recruiting |
| Hyderabad, Andhra Pradesh, India, 500034 | |
| Contact: Dr. Palanki S. Dattatreya 91-9440591396 satya_palanki@rediffmail.com | |
| NVS Ramakrishna's Clinic | Recruiting |
| Hyderabad, Andhra Pradesh, India, 500063 | |
| Contact: Dr. N V S. Ramkrishna 9949341112 rnalla@gmail.com | |
| Dr. Nikhil's Clinic | Recruiting |
| Secunderabad, Andhra Pradesh, India, 500025 | |
| Contact: Dr. Nikhil Ghadyalpatil 8008037474 nikhilghadyalpatil@gmail.com | |
| Swarna Sai Hospital | Recruiting |
| Secunderabad, Andhra Pradesh, India, 500059 | |
| Contact: Dr. C. Sairam 9849032198 brcsairam@hotmail.com | |
| Sparsh Hospital | Recruiting |
| Orissa, Bhubaneswar, India, 751007 | |
| Contact: Dr. Ghanashyam Biswas 9937500878 drgbiswas@yahoo.com | |
| All India Institute of Medical Sciences | Recruiting |
| New Delhi, Delhi, India, 110029 | |
| Contact: Dr. Atul Sharma 9818548149 atul1@hotmail.com | |
| Wellness Consultants Clinic | Recruiting |
| Surat, Gujarat, India, 395002 | |
| Contact: Dr. Tanveer Maksud 9909918887 tanveermaksud@yahoo.com | |
| Global Health Pvt Ltd | Recruiting |
| Gurgaon, Haryana, India, 122001 | |
| Contact: Dr. Ashok Vaid 9810212235 akvaid@yahoo.com | |
| The Cancer Clinic | Recruiting |
| Kochin, Kerala, India, 682304 | |
| Contact: Dr. Thomas Varughese 9447173088 drthomas.surgoncologist@gmail.com | |
| Dr. T. P. Sahoo's Clinic | Recruiting |
| Bhopal, Madhya Pradesh, India, 462001 | |
| Contact: Dr. Tarini P Sahoo 9893686246 tarini73@rediffmail.com | |
| BND Onco Centre | Recruiting |
| Mumbai, Maharashtra, India, 400014 | |
| Contact: Dr. Boman Dhabhar 9820344570 drboman@hotmail.com | |
| S.L.Raheja Hospital | Recruiting |
| Mumbai, Maharashtra, India, 400016 | |
| Contact: Dr. S. H. Advani 022-24445526 shadvani2000@yahoo.com | |
| Galaxy Care Laproscopic Institute | Recruiting |
| Pune, Maharashtra, India, 411004 | |
| Contact: Dr. S Puntambekar Puntambekar 9822023706 shase63@gmail.com | |
| Ruby Hall Clinic | Recruiting |
| Pune, Maharashtra, India, 411001 | |
| Contact: Dr. Minish Jain 9823133390 minishjain009@gmail.com | |
| S M Karandikar's Clinic | Recruiting |
| Pune, Maharashtra, India, 400014 | |
| Contact: Dr. S M Karandikar 9890281963 skaran44@gmail.com | |
| Neigrihms | Recruiting |
| Shillong, Meghalaya, India, 793005 | |
| Contact: Dr. Dillip Kumar Parida 94361-14334 dkparida@hotmail.com | |
| Grace Nursing Home | Recruiting |
| Aizwal, Mizoram, India, 796 009 | |
| Contact: Dr. Jeremy Pautu 9436150301 jlpautu@gmail.com | |
| SMS Hospital | Recruiting |
| Jaipur, Rajasthan, India, 302004 | |
| Contact: Dr. D. P. Singh 094142-63400 drdpsingh@yahoo.com | |
| Cancer Clinic | Recruiting |
| Jaipur, Rajasthan, India, 302004 | |
| Contact: Dr. Sandeep Jasuja 9549099990 sandeep.jasuja@gmail.com | |
| Bhagwan Mahaveer Cancer Hospital | Recruiting |
| Jaipur, Rajasthan, India, 302006 | |
| Contact: Dr. Naresh Somani 0141-2700107 drsomani@somexresearch.com | |
| J.K.Cancer Institute | Recruiting |
| Kanpur, Uttar Pradesh, India, 208002 | |
| Contact: Dr. Sharad Singh 9452062985 sharad_onco@yahoo.co.in | |
| Annapurna Medical and Cancer Relief Society | Recruiting |
| Lucknow, Uttar Pradesh, India, 226007 | |
| Contact: Dr. Sanjeev Mishra 9919140407 drsanjeev.mishra@gmail.com | |
| Dr. Vineet's Clinic | Recruiting |
| New Delhi, Uttar Pradesh, India, 110085 | |
| Contact: Dr. Vineet Talwar 9810241512 drvineettalwar@yahoo.com | |
| SMH-Curie Cancer Centre, Shanti Mukand Hospital | Recruiting |
| New Delhi, Uttar Pradesh, India, 110092 | |
| Contact: Dr. Sameer Khatri 9810381883 drsamkhatri@rediffmail.com | |
| Apollo Gleneagles Cancer Hospital | Recruiting |
| Kolkata, West Bengal, India, 700054 | |
| Contact: Dr. P. N. Mohapatra 9674311610 prabrajya.mohapatra@rediffmail.com | |
| B.R. Singh Hospital | Recruiting |
| Kolkatta, West Bengal, India, 700014 | |
| Contact: Dr. Madhuchanda Kar 9830155915 madhuchandakar@yahoo.com | |
| Sunil Gupta's Clinic | Recruiting |
| Delhi, India, 110092 | |
| Contact: Dr. Sunil Kumar Gupta 9811102971 drsgonco@rediffmail.com | |
Sponsors and Collaborators
Merck KGaA
Merck Ltd., India
Investigators
| Study Director: | Dr. Rajiv Rana | Merck Ltd., India |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01142869 History of Changes |
| Other Study ID Numbers: | EMR 062202-514 |
| Study First Received: | June 10, 2010 |
| Last Updated: | February 22, 2013 |
| Health Authority: | India: Ministry of Health |
Keywords provided by Merck KGaA:
|
Carcinoma, Squamous Cell Erbitux Neoplasms, Squamous Cell |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Neoplasms by Site Cetuximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013