Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT00139269
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-02'}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-02', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects'}, {'measure': 'to determine the efficacy of said combination.'}], 'secondaryOutcomes': [{'measure': 'To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.'}]}, 'conditionsModule': {'keywords': ['Advanced Squamous Cell Carcinoma', 'Squamous cell Carcinoma of Head and Neck', 'SSCHN', 'Docetaxel'], 'conditions': ['Advanced Squamous Cell Carcinoma', 'Squamous Cell Carcinoma of Head and Neck', 'SSCHN']}, 'referencesModule': {'references': [{'pmid': '11181674', 'type': 'BACKGROUND', 'citation': 'Posner MR, Glisson B, Frenette G, Al-Sarraf M, Colevas AD, Norris CM, Seroskie JD, Shin DM, Olivares R, Garay CA. Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol. 2001 Feb 15;19(4):1096-104. doi: 10.1200/JCO.2001.19.4.1096.'}, {'pmid': '12518365', 'type': 'BACKGROUND', 'citation': 'Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8. doi: 10.1002/cncr.11063.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.', 'detailedDescription': '* Treatment begins with a one hour infusion of docetaxel followed by a 1/2 hour infusion of cisplatin. 5-fluorouracil will be administered through continuous IV infusion through a portable pump for four days at home. A cycle is twenty-one days long ( 4 days of chemotherapy and 17 days of recovery).\n* During each cycle blood tests will be performed weekly. A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle.\n* If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study.\n* If significant reduction in the size of the tumor is observed after cycle 2, a third and final cycle will be performed. Followed by radiation therapy twice daily for approximately 6-7 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (SSCHN).\n* At least one bi- or uni-dimensionally measurable lesion.\n* Stage II or IV disease without evidence of distant metastasis.\n* No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN.\n* Age greater than 18 years.\n* ECOG performance status of 0 or 1.\n* Life expectancy of greater than 12 weeks.\n* Adequate bone marrow, hepatic and renal function.\n* Normal serum calcium\n\nExclusion Criteria:\n\n* Primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.\n* Patients with any non-SSCHN malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.\n* Any prior treatment with chemotherapy.\n* Prior radiotherapy to major bone marrow area (\\> 10% bone marrow) or to head and neck.\n* Current peripheral neuropathy of greater than NCI grade 2.\n* Other serious illness or medical condition\n* Concurrent treatment with corticosteroids unless chronic treatment at low doses.\n* Pregnant or lactating females or females of childbearing potential not employing adequate contraception.'}, 'identificationModule': {'nctId': 'NCT00139269', 'briefTitle': 'Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'Phase I/II Pilot Study of Induction Chemotherapy With Docetaxel in Combination With Cisplatin and 5-Fluorouracil (5-FU) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)', 'orgStudyIdInfo': {'id': '97-199'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Docetaxel', 'type': 'DRUG'}, {'name': 'Cisplatin', 'type': 'DRUG'}, {'name': '5-Fluorouracil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marshall Posner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farbar Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}]}}}