Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT00378404
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2006-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D011827', 'term': 'Radiation'}], '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': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-03', 'studyFirstSubmitDate': '2006-09-18', 'studyFirstSubmitQcDate': '2006-09-19', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the MTD of low-dose fractionated radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer in the second-line setting.', 'timeFrame': 'continuously through treatment'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': 'continuously throughout treatment'}, {'measure': 'To investigate in an exploratory manner, the association of p53, p21^waf1/cip1, bcl-xL, bcl-2 and bax markers in pre- and post-treatment biopsies with patient response and toxicity.', 'timeFrame': 'week 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSCLC', 'Non-Small Cell Lung Cancer', 'Non-Small Cell', 'Lung Cancer', 'Docetaxel', 'Radiation', 'Metastatic', 'Recurrent'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://markey.uky.edu/studysearch', 'label': 'University of Kentucky Markey Cancer Center Clinical Trials Listing'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for second-line therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 18 years of age or greater.\n* Histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen.\n* Patients who have recurred after previous surgery and/or radiation may participate in this trial.\n* Patients may have had prior neoadjuvant or adjuvant therapy.\n* Patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration.\n* Measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable or non-measurable disease must be present outside the area of surgical resection. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.\n* Progression after at least one prior platinum-based chemotherapy.\n* Greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration.\n* ANC ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration.\n* Adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (SGOT or SGPT) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration.\n* Patients requiring lung radiation must have an FEV1 of \\> 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with DLCO.\n* Zubrod Performance Status of 0,1 or 2.\n\nExclusion Criteria:\n\n* No prior single-agent, weekly Docetaxel chemotherapy.\n* Peripheral neuropathy ≥ Grade 1.\n* Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years.\n* Pregnant or nursing women.'}, 'identificationModule': {'nctId': 'NCT00378404', 'briefTitle': 'Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'A Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': '04-LUN-69-UKY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Docetaxel', 'Radiation: Radiation']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'description': '30 mg/m2 IV on days 1, 8, 15 every 28 days for 6 cycles', 'armGroupLabels': ['1']}, {'name': 'Radiation', 'type': 'RADIATION', 'description': '50 - 80 cGy on days 1, 8, 15 every 28 days for 6 cycles', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Susanne Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Susanne Arnold', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kentucky Lung Cancer Research Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Susanne Arnold', 'investigatorAffiliation': 'University of Kentucky'}}}}