Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 4:31 PM
Study NCT ID:
NCT00003908
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9902 Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent 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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-17', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-05-20', 'lastUpdatePostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Weekly while on protocol treatment, then every 3 months for 1 year, then every 6 months for 2 years.', 'description': 'Overall survival was defined as the duration from the date of registration to the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'Every 6 weeks until progression of disease.', 'description': 'Progression-Free Survival was defined as the duration between the date of registration and the date of first documentation of progression of disease or death due to any cause. Progression of disease was defined as a 50% increase in the sum of products of perpendicular diameters of measurable lesions or an increase of at least 10 square centimeters, whichever was smaller, or clear worsening of non-measurable lesions in the opinion of the treating investigator, appearance of new lesions, reappearance of lesions that had previously disappeared, or symptomatic deterioration.'}, {'measure': 'Response', 'timeFrame': 'Every 6 weeks while on protocol treatment.', 'description': 'Response was defined as a confirmed or unconfirmed complete or partial response. A complete response (CR) was defined as disappearance of all disease. A partial response (PR) was defined as a 50% decrease or greater in the sum of perpendicular diameters of all measurable lesions. A CR or PR was defined as confirmed if there were two consecutive determinations at least 3 weeks apart.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent metastatic squamous neck cancer with occult primary', 'metastatic squamous neck cancer with occult primary squamous cell carcinoma', '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'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '17530488', 'type': 'RESULT', 'citation': 'Samlowski WE, Moon J, Kuebler JP, Nichols CR, Gandara DR, Ozer H, Williamson SK, Atkins JN, Schuller DE, Ensley JF. Evaluation of the combination of docetaxel/carboplatin in patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN): a Southwest Oncology Group Phase II study. Cancer Invest. 2007 Apr-May;25(3):182-8. doi: 10.1080/07357900701209061.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have metastatic or recurrent head and neck cancer.', 'detailedDescription': 'OBJECTIVES: I. Assess the survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck receiving docetaxel and carboplatin. II. Assess time to treatment failure and response rate (unconfirmed and confirmed complete and partial response) in this patient population. III. Evaluate the toxicities of this regimen in this patient population.\n\nOUTLINE: Patients receive docetaxel IV over 1 hour immediately followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually thereafter until death.\n\nPROJECTED ACCRUAL: A total of 62 patients will be accrued for this study over 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck Metastatic disease at diagnosis OR Persistent, metastatic or recurrent disease following surgery and/or radiotherapy No newly diagnosed nonmetastatic disease Bidimensionally measurable disease Demonstrated progressive disease if only measurable site is within a previous radiotherapy port\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT or SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Calcium no greater than upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or any adequately treated stage I or II cancer that is currently in complete remission No neuropathy sensory greater than grade 1 No history of hypersensitivity reaction to Polysorbate 80\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior carboplatin or cisplatin No prior chemotherapy for recurrent disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except oral contraceptives or treatment for osteoporosis) Radiotherapy: See Disease Characteristics At least 28 days since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 28 days since prior surgery and recovered'}, 'identificationModule': {'nctId': 'NCT00003908', 'briefTitle': 'S9902 Docetaxel Plus Carboplatin in Treating Patients With Metastatic or Recurrent Head and Neck Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Evaluation of the Combination of Docetaxel (Taxotere)/ Carboplatin in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)', 'orgStudyIdInfo': {'id': 'CDR0000067086'}, 'secondaryIdInfos': [{'id': 'S9902', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'docetaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'MBCCOP - University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Greater Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Phoenix (Hayden)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - 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Seattle', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405-0986', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Northwest', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Wolfram E. Samlowski, MD, BA', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}