Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-01 @ 12:44 PM
Study NCT ID:
NCT00035035
Status:
COMPLETED
Last Update Posted:
2006-07-19
First Post:
2002-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'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': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2006-07', 'lastUpdateSubmitDate': '2006-07-18', 'studyFirstSubmitDate': '2002-05-02', 'studyFirstSubmitQcDate': '2002-05-02', 'lastUpdatePostDateStruct': {'date': '2006-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Pancreas', 'Cancer', 'Unresectable or Metastatic Cancer of the Pancreas', 'Alimta'], 'conditions': ['Pancreatic Neoplasms', 'Metastases, Neoplasm']}, 'descriptionModule': {'briefSummary': 'Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body.\n* You must have one tumor that can be physically measured or scanned by the doctor.\n* You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU.\n* You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis.\n\nExclusion Criteria:\n\n* Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study.\n* Documentation that the cancer has spread to your brain.\n* Pregnant or breastfeeding.\n* A second primary cancer.\n* Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.'}, 'identificationModule': {'nctId': 'NCT00035035', 'briefTitle': 'A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.', 'nctIdAliases': ['NCT00049426'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.', 'orgStudyIdInfo': {'id': '5148'}, 'secondaryIdInfos': [{'id': 'H3E-MC-JMES'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'GEMZAR', 'type': 'DRUG'}, {'name': 'ALIMTA', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': 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