Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT00012220
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2001-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2001-03-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '4 years post treatment'}], 'secondaryOutcomes': [{'measure': 'Time to disease progression', 'timeFrame': 'treatment up to 4 years post treatment'}, {'measure': 'Toxicity', 'timeFrame': 'treatment and up to 4 years post treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adenocarcinoma of the pancreas', 'stage IV pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '19858396', 'type': 'RESULT', 'citation': 'Kulke MH, Tempero MA, Niedzwiecki D, Hollis DR, Kindler HL, Cusnir M, Enzinger PC, Gorsch SM, Goldberg RM, Mayer RJ. Randomized phase II study of gemcitabine administered at a fixed dose rate or in combination with cisplatin, docetaxel, or irinotecan in patients with metastatic pancreatic cancer: CALGB 89904. J Clin Oncol. 2009 Nov 20;27(33):5506-12. doi: 10.1200/JCO.2009.22.1309. Epub 2009 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the overall survival rate of patients with metastatic pancreatic cancer treated with gemcitabine alone vs with cisplatin vs with docetaxel vs with irinotecan.\n* Compare the time to disease progression in patients treated with these regimens.\n* Compare the CA 19-9 biomarker response in patients treated with these regimens.\n* Correlate the CA 19-9 biomarker response with survival in patients treated with these regimens.\n* Compare the toxicity of these regimens in these patients.\n* Compare the response in patients with measurable disease treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms.\n\n* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.\n* Arm III: Patients receive gemcitabine IV over 30 minutes followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.\n* Arm IV: Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 1 year and then every 6 months for 3 years.\n\nPROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study within 30 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the pancreas\n* Metastatic disease by CT scan\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* CTC 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT no greater than 2.5 times upper limit of normal (ULN)\n* Alkaline phosphatase less than 2.5 times ULN if SGOT greater than 1.5 times ULN\n* Alkaline phosphatase any value if SGOT less than 1.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study\n* No other currently active malignancy (completed therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nChemotherapy:\n\n* No prior chemotherapy except fluorouracil (5-FU)\n* At least 2 weeks since prior 5-FU\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy except steroids for adrenal failure, hormonal therapy for non-disease related conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an antiemetic\n\nRadiotherapy:\n\n* At least 2 weeks since prior radiotherapy\n* No concurrent palliative radiotherapy except whole-brain irradiation for CNS disease'}, 'identificationModule': {'nctId': 'NCT00012220', 'briefTitle': 'Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CALGB-89904'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CALGB-89904'}, {'id': 'CDR0000068495', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine', 'description': 'Standard treatment', 'interventionNames': ['Drug: gemcitabine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcitabine + cisplastin', 'description': 'Addition of cisplastin to gemcitabine', 'interventionNames': ['Drug: cisplatin', 'Drug: gemcitabine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcitabine + docetaxel', 'description': 'Addition of docetaxel to gemcitabine', 'interventionNames': ['Drug: docetaxel', 'Drug: gemcitabine hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcitabine + Irinotecan', 'description': 'Addition of irinotecan to gemcitabine', 'interventionNames': ['Drug: gemcitabine hydrochloride', 'Drug: irinotecan hydrochloride']}], 'interventions': [{'name': 'cisplatin', 'type': 'DRUG', 'description': '50 mg/sq m IV infusion over 30 min on Days 1 \\& 15 of ea cycle', 'armGroupLabels': ['Gemcitabine + cisplastin']}, {'name': 'docetaxel', 'type': 'DRUG', 'description': '40 mg/sq m IV infusion over 60 min on Days 1 \\& 8 of ea treatment cycle', 'armGroupLabels': ['Gemcitabine + docetaxel']}, {'name': 'gemcitabine hydrochloride', 'type': 'DRUG', 'description': 'Gemcitabine only arm: 1500 mg/sq m in 250 mL NS IV infusion over 150 min Days 1, 8, \\& 15 of ea cycle\n\n* cisplastin arm: 1000 mg/sq m 250 mL NS IV infusion over 30 min Days 1, 8, 15 of ea cycle\n* docetaxel and + irinotecan arms: 1000 mg/sq m in 250 mL NS IV infusion over 30 min Days 1 \\& 8 of ea cycle', 'armGroupLabels': ['Gemcitabine', 'Gemcitabine + Irinotecan', 'Gemcitabine + cisplastin', 'Gemcitabine + docetaxel']}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG', 'description': '100 mg/q m in 500 mL D5W or D5NS IV infusion over 90 min Days 1 \\& 8 of ea cycle', 'armGroupLabels': ['Gemcitabine + Irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northeast Alabama Regional Medical Center', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '92093-0658', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Rebecca and John Moores UCSD Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Lombardi Cancer Center', 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