Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-28 @ 8:26 AM
Study NCT ID:
NCT00006361
Status:
COMPLETED
Last Update Posted:
2009-12-04
First Post:
2000-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009382', 'term': 'Neoplasms, Unknown Primary'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C116890', 'term': 'Semaxinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-12', 'lastUpdateSubmitDate': '2009-12-03', 'studyFirstSubmitDate': '2000-10-04', 'studyFirstSubmitQcDate': '2003-05-29', 'lastUpdatePostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['squamous cell carcinoma of the skin', 'recurrent skin cancer', 'stage IV nasopharyngeal cancer', 'recurrent metastatic squamous neck cancer with occult primary', 'metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'squamous cell carcinoma of unknown primary', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the nasopharynx', 'recurrent squamous cell carcinoma of the nasopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent carcinoma of unknown primary'], 'conditions': ['Carcinoma of Unknown Primary', 'Head and Neck Cancer', 'Non-melanomatous Skin Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Zahalsky AJ, Wong RJ, Lis E, et al.: Phase II trial of SU5416 in patients with advanced incurable head and neck cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-902, 2002.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: SU5416 may stop the growth of cancer cells by stopping blood flow to the tumor.\n\nPURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have advanced or recurrent cancer of the head and neck.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effect of SU5416 on survival and tumor response in patients with advanced or recurrent squamous cell carcinoma of the head and neck.\n* Determine the safety and toxicity of SU5416 in these patients.\n\nOUTLINE: Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed for 1 year.\n\nPROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 1.4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven epidermoid/squamous cell carcinoma of the oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx; undifferentiated carcinoma of the nasopharynx (WHO type III); sinonasal undifferentiated carcinoma; or squamous cell carcinoma of unknown primary or the skin with initial presentation in the head and neck region\n* Advanced or recurrent disease that is incurable with surgery or radiotherapy\n* No more than 2 prior cytotoxic chemotherapy regimens for recurrent, persistent, or metastatic disease\n\n * Prior exposure to chemopreventive agents (e.g., tretinoin or other vitamin analogues) is not considered to be a prior cytotoxic chemotherapy exposure\n* At least 1 measurable indicator lesion\n\n * Bone metastases, elevated enzyme levels, or lesions on radionuclide scans are not acceptable as the sole parameters of measurable disease\n* No history of brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,000/mm3\n* Hemoglobin greater than 8 g/dL\n* Platelet count greater than 100,000/mm3\n* No history of coagulation disorder\n\nHepatic:\n\n* Bilirubin normal\n* SGOT less than 2.5 times upper limit of normal\n* PT no greater than 14 seconds\n* aPTT no greater than 40 seconds\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No uncompensated coronary artery disease\n* No myocardial infarction or severe/unstable angina within the past 6 months\n* No severe peripheral vascular disease associated with diabetes mellitus\n* No deep venous or arterial thrombosis within the past 3 months\n* No unstable cardiac rhythm\n* No cerebrovascular accident within the past 6 months\n\nPulmonary:\n\n* No pulmonary embolism within the past 3 months\n\nOther:\n\n* No history of allergic reaction to paclitaxel\n* No other active malignancy except:\n\n * Basal cell or squamous cell skin cancer\n * Carcinoma in situ of the cervix\n * Synchronous epidermoid/squamous cell carcinoma of the head and neck (oral cavity, lip, hypopharynx, oropharynx, nasopharynx, sinonasal tract, or larynx)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active bacterial infection requiring antibiotics\n* No other concurrent medical condition that would increase risk\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00006361', 'briefTitle': 'SU5416 in Treating Patients With Advanced or Recurrent Cancer of the Head and Neck', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'CDR0000068232'}, 'secondaryIdInfos': [{'id': 'MSKCC-00049'}, {'id': 'NCI-79'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'semaxanib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David G. Pfister, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}