Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-03 @ 7:56 PM
Study NCT ID:
NCT00113256
Status:
TERMINATED
Last Update Posted:
2024-08-02
First Post:
2005-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079905', 'term': 'rubitecan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2005-06-06', 'studyFirstSubmitQcDate': '2005-06-06', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival'}]}, 'conditionsModule': {'keywords': ['rubitecan', 'Orathecin', '9-nitrocamptothecin', 'gemcitabine', 'Gemzar', 'pancreatic cancer', 'adenocarcinoma', 'RFS 2000'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'Patients will be treated with gemcitabine and Orathecin (rubitecan) capsules to evaluate the current estimate of overall survival as a study endpoint prior to launching the blinded randomized phase (versus gemcitabine and placebo) of the study. Toxicity of the drug combination will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient is at least 18 years of age.\n* The patient has histologically or cytologically confirmed, non-resectable, Stage II-IV primary adenocarcinoma of the pancreas.\n* The patient has had a baseline computed tomography (CT) scan, or magnetic resonance imaging (MRI), to evaluate tumor(s) within 28 days prior to randomization.\n* The patient has never been treated with prior chemotherapy, with the exception of low-dose 5-fluorouracil (5-FU) as a radiation sensitizer.\n* The patient has sufficiently recovered from the effects of previous surgery (no less than 3 weeks prior to randomization), radiotherapy, and/or immunotherapy (no less than 4 weeks prior to randomization).\n* The patient's estimated life expectancy is at least 12 weeks.\n* The patient has a Karnofsky Performance Status between 50 and 100.\n* The patient has adequate bone marrow function.\n* The patient has adequate hepatic and renal function.\n\nExclusion Criteria:\n\n* The patient has any active, uncontrolled infection requiring antibiotics.\n* The patient has any serious, uncontrolled concomitant systemic disorder.\n* The patient has surgery scheduled within 8 weeks following initiation of treatment.\n* The patient is pregnant or nursing.\n* The patient is not capable of consistent oral intake of at least 3 L/day of fluid and/or requires constant intravenous (IV) hydration or frequent tube feeding.\n* The patient is receiving any investigational agent(s) or has been a participant in a clinical trial within the last 30 days."}, 'identificationModule': {'nctId': 'NCT00113256', 'briefTitle': 'Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astex Pharmaceuticals, Inc.'}, 'officialTitle': 'Randomized Trial of Orathecin and Gemcitabine Versus Placebo and Gemcitabine in Patients With Non-Resectable Pancreatic Cancer Who Have Not Already Received Chemotherapy', 'orgStudyIdInfo': {'id': 'SGI-RUB-048'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rubitecan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92882', 'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Cancer Care Medical Group', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': '11100 Warner Avenue, Ste. 200', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '95073', 'city': 'Soquel', 'state': 'California', 'country': 'United States', 'facility': 'The Cancer Research & Prevention Center', 'geoPoint': {'lat': 36.98801, 'lon': -121.95663}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Mile High Oncology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare, Inc.', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Mary Bird Perkins Cancer Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Medical Oncology', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'N. Mississippi Hematology & Oncology Associates', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City Cancer Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Cancer Research of Long Island', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Charleston Hematology Oncology, PA', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astex Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}