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The study was discontinued due to slow recruitment and subjects not completing follow up period.
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| Name | Class |
|---|---|
| Merck Ltd., India | INDUSTRY |
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN. | 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) | From first infusion of cetuximab until 28 days after the last infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN. | Clinical efficacy will be assessed by best tumor response, disease control rate, progression-free survival and overall survival with cetuximab treatment. | From first infusion of cetuximab until 28 days after the last infusion. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with squamous cell carcinoma of head and neck
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Rajiv Rana | Merck Ltd., India | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambaa Hospitals | Hyderabad | Andhra Pradesh | 500008 | India | ||
| Indo- American Cancer Institute & Research Centre |
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Whole Blood
| Hyderabad |
| Andhra Pradesh |
| 500034 |
| India |
| NVS Ramakrishna's Clinic | Hyderabad | Andhra Pradesh | 500063 | India |
| Dr. Nikhil's Clinic | Secunderabad | Andhra Pradesh | 500025 | India |
| Swarna Sai Hospital | Secunderabad | Andhra Pradesh | 500059 | India |
| Sparsh Hospital | Orissa | Bhubaneswar | 751007 | India |
| Wellness Consultants Clinic | Surat | Gujarat | 395002 | India |
| Global Health Pvt Ltd | Gurgaon | Haryana | 122001 | India |
| The Cancer Clinic | Kochi | Kerala | 682304 | India |
| Dr. T. P. Sahoo's Clinic | Bhopal | Madhya Pradesh | 462001 | India |
| BND Onco Centre | Mumbai | Maharashtra | 400014 | India |
| S.L.Raheja Hospital | Mumbai | Maharashtra | 400016 | India |
| S M Karandikar's Clinic | Pune | Maharashtra | 400014 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Galaxy Care Laproscopic Institute | Pune | Maharashtra | 411004 | India |
| Neigrihms | Shillong | Meghālaya | 793005 | India |
| Grace Nursing Home | Aizawl | Mizoram | 796 009 | India |
| All India Institute of Medical Sciences | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Cancer Clinic | Jaipur | Rajasthan | 302004 | India |
| SMS Hospital | Jaipur | Rajasthan | 302004 | India |
| Bhagwan Mahaveer Cancer Hospital | Jaipur | Rajasthan | 302006 | India |
| J.K.Cancer Institute | Kanpur | Uttar Pradesh | 208002 | India |
| Annapurna Medical and Cancer Relief Society | Lucknow | Uttar Pradesh | 226007 | India |
| Dr. Vineet's Clinic | New Delhi | Uttar Pradesh | 110085 | India |
| SMH-Curie Cancer Centre, Shanti Mukand Hospital | New Delhi | Uttar Pradesh | 110092 | India |
| B.R. Singh Hospital | Kolkata | West Bengal | 700014 | India |
| Apollo Gleneagles Cancer Hospital | Kolkata | West Bengal | 700054 | India |
| Sunil Gupta's Clinic | Delhi | 110092 | India |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D018307 | Neoplasms, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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