Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-01-01 @ 1:00 AM
Study NCT ID:
NCT00080028
Status:
TERMINATED
Last Update Posted:
2007-05-08
First Post:
2004-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D007012', 'term': 'Hypopharyngeal Neoplasms'}, {'id': 'D014067', 'term': 'Tonsillar Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C437683', 'term': 'motexafin gadolinium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 18}}, 'statusModule': {'overallStatus': 'TERMINATED', 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-04', 'studyFirstSubmitDate': '2004-03-22', 'studyFirstSubmitQcDate': '2004-03-22', 'lastUpdatePostDateStruct': {'date': '2007-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Head and Neck Cancer', 'SCCHN', 'Oropharynx Cancer', 'Hypopharynx Cancer', 'Larynx Cancer', 'Soft palate Cancer', 'Tonsil Cancer', 'Base of tongue Cancer', 'Supraglottic Cancer', 'Glottic Cancer', 'Pyriform Sinus Cancer', 'Pharyngeal wall Cancer', 'Throat cancer'], 'conditions': ['Head and Neck Cancer', 'Oropharynx Cancer', 'Larynx Cancer', 'Hypopharynx Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Each patient must sign a study-specific informed consent form\n* Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI\n* Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin\n* Karnofsky Performance Status score of at least 60%\n* Primary tumor at least 4 cm in diameter\n\nExclusion Criteria:\n\nLaboratory Values of:\n\n* Serum creatinine \\> 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min\n* Serum total bilirubin \\> 1.5 times the upper limit of normal\n* ALT (formerly SGPT) \\> 1.5 times the upper limit of normal\n* Alkaline phosphatase \\> 1.5 times the upper limit of normal\n* Absolute neutrophil count (ANC) \\< 1500/L\n* Platelet count \\< 100,000/L\n* 3+ or greater proteinuria on urinalysis\n\nand\n\n* Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx\n* Distant metastases\n* Prior history of cancer at any site treated with radiotherapy and/or chemotherapy\n* History of SCCHN diagnosed within 5 years of current diagnosis'}, 'identificationModule': {'nctId': 'NCT00080028', 'briefTitle': 'Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmacyclics LLC.'}, 'officialTitle': 'Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'PCYC-0210'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Motexafin Gadolinium Injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, San Antonio Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacyclics LLC.', 'class': 'INDUSTRY'}}}}