Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT00278460
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2006-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D002282', 'term': 'Adenocarcinoma, Bronchiolo-Alveolar'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], '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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2006-01-16', 'studyFirstSubmitQcDate': '2006-01-16', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient response rate to weekly taxotere and gemcitabine', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluate toxicity of weekly Taxotere and Gemcitabine', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer', 'adenocarcinoma of the lung', 'bronchoalveolar cell lung cancer', 'large cell lung cancer', 'recurrent non-small cell lung cancer', 'squamous cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.\n* Determine the overall and progression-free survival of patients treated with this regimen.\n* Determine the toxic effects of this regimen in these patients.\n\nSecondary\n\n* Determine the duration of response in patients treated with this regimen.\n\nOUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed periodically for survival.\n\nPROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types:\n\n * Squamous cell carcinoma\n * Adenocarcinoma, including bronchoalveolar cell adenocarcinoma\n * Large cell anaplastic carcinoma, including giant and clear cell carcinomas\n* Histologic or cytologic documentation of recurrence is required\n* Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging\n\n * The following lesions are not considered measurable or evaluable:\n\n * Bone disease only\n * Pleural or pericardial effusions\n * Previously irradiated lesions, unless subsequent progression is documented\n* CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* Negative pregnancy test\n* CALGB performance status ≤ 1\n* Life expectancy ≥ 3 months\n* Granulocyte count \\> 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Creatinine ≤ 2 times normal\n* Bilirubin normal\n* SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR\n* Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal\n* Ejection fraction normal by ECHO or MUGA\n* No history of congestive heart failure\n* No psychiatric illness that would preclude study compliance\n* No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to \\< 3 months\n* No active uncontrolled bacterial, fungal, or viral infection\n* No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy\n* No pre-existing peripheral neuropathy ≥ grade 2\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 2 weeks since prior major surgery and recovered from acute effects\n* At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects\n\n * Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed\n* No prior chemotherapy\n* No concurrent cranial or thoracic radiation therapy\n* No concurrent cytotoxic or hormonal therapy\n* Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction'}, 'identificationModule': {'nctId': 'NCT00278460', 'briefTitle': 'Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CDR0000462116'}, 'secondaryIdInfos': [{'id': 'CCCWFU-62199'}, {'id': 'AVENTIS-CCCWFU-62199'}, {'id': 'AG-CCCWFU-62199'}, {'id': 'CCCWFU-BG99-322'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'docetaxel', 'type': 'DRUG', 'description': '40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days'}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'description': '800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Antonius A. Miller, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}