Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT00003193
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV 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': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D004999', 'term': 'Amifostine'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D063086', 'term': 'Organothiophosphates'}, {'id': 'D010755', 'term': 'Organophosphates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009946', 'term': 'Organothiophosphorus Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-04-22', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Survival', 'timeFrame': '5 years', 'description': 'Percentage of patients alive at 5 years as well as the median overal survival were determined.'}], 'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '6 months', 'description': 'Safety is evaluated in this dose-escalation study'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '6 months', 'description': 'Response in terms of CR, PR, stable disease, or progression was determined'}]}, 'conditionsModule': {'keywords': ['oral complications', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the nasopharynx', 'stage IV squamous cell carcinoma of the nasopharynx', 'stage III squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx', 'stage III squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity'], 'conditions': ['Head and Neck Cancer', 'Oral Complications']}, 'referencesModule': {'references': [{'pmid': '16116597', 'type': 'RESULT', 'citation': 'Amrein PC, Clark JR, Supko JG, Fabian RL, Wang CC, Colevas AD, Posner MR, Deschler DG, Rocco JW, Finkelstein DM, McIntyre JF. Phase I trial and pharmacokinetics of escalating doses of paclitaxel and concurrent hyperfractionated radiotherapy with or without amifostine in patients with advanced head and neck carcinoma. Cancer. 2005 Oct 1;104(7):1418-27. doi: 10.1002/cncr.21312.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.\n\nPURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of paclitaxel with amifostine and radiotherapy in patients with stage III or IV head and neck cancer.\n* Determine the toxic effects and complications of this regimen in terms of mucositis reduction in these patients.\n* Determine the complete response rate and progression-free survival of patients treated with this regimen.\n* Determine whether amifostine modulates the plasma pharmacokinetics of paclitaxel in these patients.\n\nOUTLINE: This is a dose-escalation study of paclitaxel with and without amifostine.\n\nPatients receive paclitaxel IV on days 1, 8, 15, 29, 36, and 43 for a total of 3-6 doses. Patients also undergo radiotherapy twice daily for 6 weeks, except for days when paclitaxel is given.\n\nCohorts of 2-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2-3 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD.\n\nAfter determination of the MTD for paclitaxel, subsequent patients also receive amifostine IV over 15 minutes on days 1, 8, 29, and 36 and radiotherapy on days 2-5 and 30-33. Determination of the MTD for this drug combination is carried out as with paclitaxel alone.\n\nAt 4 to 8 weeks after the last treatment of radiotherapy, patients undergo CT scanning to determine response. Patients with residual masses undergo neck dissection. Patients with complete or partial response at the primary site are followed without surgery.\n\nPatients are followed every 6 months.\n\nPROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage III or IV squamous cell head and neck cancer\n\n * T3-4, N0-3, M0\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance Status:\n\n* ECOG 0-2\n\nLife Expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 2,000/mm\\^3\n* Platelet count at least 50,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 3.0 mg/dL\n* SGOT no greater than 3 times upper limit of normal\n\nRenal:\n\n* Creatinine no greater than 3.0 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* No concurrent beta-adrenergic blocking agents'}, 'identificationModule': {'nctId': 'NCT00003193', 'briefTitle': 'Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase I/II Study of Escalating Doses of Taxol Used Concurrently With Ethyol and Accelerated Hyperfractionated Radiotherapy in the Treatment of Stage III and IV Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'CDR0000066028'}, 'secondaryIdInfos': [{'id': 'MGH-M7-20'}, {'id': 'ALZA-97-024-ii'}, {'id': 'NCI-V98-1384'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paclitaxel, amifostine, RT', 'description': 'Dose-escalation arm for paclitaxel with amifostine and RT.', 'interventionNames': ['Drug: amifostine trihydrate', 'Drug: paclitaxel', 'Procedure: conventional surgery', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'amifostine trihydrate', 'type': 'DRUG', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}, {'name': 'paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Philip C. Amrein, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Philip C. Amrein, M.D.', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}