Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00003202
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With 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'}], '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': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-11-25', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '•Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'assess the efficacy of dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy', 'timeFrame': '72 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['squamous cell lung cancer', 'large cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'adenocarcinoma of the lung', 'adenosquamous cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.\n\nPURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy alone or following 2 cycles of induction chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer.\n* Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients.\n* Determine the effectiveness of concurrent radiation and gemcitabine by determining the complete response rate, partial response rate, time to recurrence, pattern of recurrence, and overall survival in a cohort of these patients.\n\nOUTLINE: This is an alternating two arm, dose escalation, multicenter study.\n\nArm I: Patients receive twice-weekly gemcitabine as a 30 minute infusion. Concurrent radiation therapy is administered 5 days a week for 6 weeks.\n\nArm II: Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a 30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1. Each cycle is 21 days. Patients then receive gemcitabine and radiation therapy as in arm I.\n\nCohorts of 3 patients are enrolled into each treatment arm at each dose level of gemcitabine. Toxicity for each arm is assessed independently. Once dose limiting toxicity (DLT) is observed at any dose level, 3 more patients are enrolled at the same dose level. The maximum tolerated dose (MTD) is defined as the dose at which no more than 1 of 6 patients experiences grade 4 toxicity, or no more than 4 of 6 patients experience grade 3 or worse toxicity (DLT). After the MTD is determined for each treatment arm, additional patients are treated at that dose level for the phase II portion of the study.\n\nPatients are followed every 3 months for 2 years, then every 4 months for the next 2 years, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: There will be approximately 24-48 patients accrued into this study within 1-2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable, including the following cellular types:\n\n * Squamous cell carcinoma\n * Adenocarcinoma\n * Bronchoalveolar carcinoma\n * Large cell anaplastic carcinoma\n * Non-small cell lung cancer not otherwise specified\n* Tumors may be multifocal if all of disease is believed to be result of direct spread\n* Disease must be fully accessible by radiotherapy ports for the entire prescribed dose\n* No supraclavicular nodes or diffuse pleural involvement\n* No contralateral hilar disease or an exudative, bloody, or cytologically malignant effusion\n* Measurable disease required for phase II of this study\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 1 year\n\nHematopoietic:\n\n* Granulocyte count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n* Hemoglobin greater than 10 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n\nRenal:\n\n* BUN no greater than 1.5 times normal\n* Creatinine no greater than 1.5 times normal\n\nPulmonary:\n\n* FEV1 no greater than 1 liter except if tumor has negatively impacted\n* pulmonary function\n\nOther:\n\n* No other serious medical or psychiatric illness\n* No prior lung cancer except if free of disease for more than 3 years\n* No other prior malignancy except nonmelanoma skin cancer or if free of\n* disease for more than 1 year\n* Not pregnant or nursing\n* Negative pregnancy test\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior thoracic radiotherapy\n* Concurrent radiotherapy to other anatomic sites allowed\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00003202', 'briefTitle': 'Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': "Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)", 'orgStudyIdInfo': {'id': 'CDR0000066052'}, 'secondaryIdInfos': [{'id': 'CCCWFU-62197'}, {'id': 'NCI-G98-1386'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157-1082', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Arthur William Blackstock, 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'}}}}