Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-29 @ 2:53 AM
Study NCT ID:
NCT01142869
Status:
TERMINATED
Last Update Posted:
2017-05-08
First Post:
2010-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'whyStopped': 'The study was discontinued due to slow recruitment and subjects not completing follow up period.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2010-06-10', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.', 'timeFrame': 'From first infusion of cetuximab until 28 days after the last infusion.', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.', 'timeFrame': 'From first infusion of cetuximab until 28 days after the last infusion.', 'description': 'Clinical efficacy will be assessed by best tumor response, disease control rate, progression-free survival and overall survival with cetuximab treatment.'}]}, 'conditionsModule': {'keywords': ['Carcinoma, Squamous Cell', 'Erbitux', 'Neoplasms, Squamous Cell'], 'conditions': ['Carcinoma, Squamous Cell']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with squamous cell carcinoma of head and neck', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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."\n* For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.\n\nExclusion Criteria:\n\n* Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria \\[NCI-CTC\\]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab'}, 'identificationModule': {'nctId': 'NCT01142869', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck KGaA, Darmstadt, Germany'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'EMR 062202-514'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cetuximab', 'type': 'DRUG', 'otherNames': ['Erbitux'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '500008', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Ambaa Hospitals'}, {'zip': '500034', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Indo- American Cancer Institute & Research Centre'}, {'zip': '500063', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': "NVS Ramakrishna's Clinic"}, {'zip': '500025', 'city': 'Secunderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': "Dr. Nikhil's Clinic"}, {'zip': '500059', 'city': 'Secunderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Swarna Sai Hospital'}, {'zip': '751007', 'city': 'Orissa', 'state': 'Bhubaneswar', 'country': 'India', 'facility': 'Sparsh Hospital'}, {'zip': '395002', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Wellness Consultants Clinic', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '122001', 'city': 'Gurgaon', 'state': 'Haryana', 'country': 'India', 'facility': 'Global Health Pvt Ltd', 'geoPoint': {'lat': 28.4601, 'lon': 77.02635}}, {'zip': '682304', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'The Cancer Clinic', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '462001', 'city': 'Bhopal', 'state': 'Madhya Pradesh', 'country': 'India', 'facility': "Dr. T. P. Sahoo's Clinic", 'geoPoint': {'lat': 23.25469, 'lon': 77.40289}}, {'zip': '400014', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'BND Onco Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400016', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'S.L.Raheja Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '400014', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': "S M Karandikar's Clinic", 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Ruby Hall Clinic', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Galaxy Care Laproscopic Institute', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '793005', 'city': 'Shillong', 'state': 'Meghālaya', 'country': 'India', 'facility': 'Neigrihms', 'geoPoint': {'lat': 25.56892, 'lon': 91.88313}}, {'zip': '796 009', 'city': 'Aizawl', 'state': 'Mizoram', 'country': 'India', 'facility': 'Grace Nursing Home', 'geoPoint': {'lat': 23.72894, 'lon': 92.71791}}, {'zip': '110029', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '302004', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Cancer Clinic', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302004', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'SMS Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '302006', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Bhagwan Mahaveer Cancer Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '208002', 'city': 'Kanpur', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'J.K.Cancer Institute', 'geoPoint': {'lat': 26.46523, 'lon': 80.34975}}, {'zip': '226007', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'Annapurna Medical and Cancer Relief Society', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '110085', 'city': 'New Delhi', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': "Dr. Vineet's Clinic"}, {'zip': '110092', 'city': 'New Delhi', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'SMH-Curie Cancer Centre, Shanti Mukand Hospital'}, {'zip': '700014', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'B.R. Singh Hospital', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '700054', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Apollo Gleneagles Cancer Hospital', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '110092', 'city': 'Delhi', 'country': 'India', 'facility': "Sunil Gupta's Clinic", 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'overallOfficials': [{'name': 'Dr. Rajiv Rana', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Ltd., India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Ltd., India', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}