Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00003018
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
1999-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer
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': 'D004176', 'term': 'Dipyridamole'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-02', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-21', 'lastUpdatePostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Response rate in patients with measurable disease', 'timeFrame': 'From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months'}, {'measure': 'Toxicities', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months'}, {'measure': 'Resectability of patents who respond to this regimen', 'timeFrame': 'From date of registration until the date of patients achieving complete or partial response assessed up to 100 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II pancreatic cancer', 'stage III pancreatic cancer', 'duct cell adenocarcinoma of the pancreas'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '17470859', 'type': 'RESULT', 'citation': 'Isacoff WH, Bendetti JK, Barstis JJ, Jazieh AR, Macdonald JS, Philip PA. Phase II trial of infusional fluorouracil, leucovorin, mitomycin, and dipyridamole in locally advanced unresectable pancreatic adenocarcinoma: SWOG S9700. J Clin Oncol. 2007 May 1;25(13):1665-9. doi: 10.1200/JCO.2006.06.7637.'}, {'type': 'RESULT', 'citation': 'Isacoff WH, Benedetti J, MacDonald JS, et al.: Continuous infusion (CI) 5 fluorouracil (5FU), leucovorin (LV), mitomycin C (Mito C) and dipyridamole (D) in patients with locally advanced unresectable pancreatic adenocarcinoma - a phase II trial of the Southwest Oncology Group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-544, 2002.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.', 'detailedDescription': 'OBJECTIVES: I. Assess the one year overall survival rate of patients with advanced, unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and dipyridamole. II. Assess the response rate in this group of patients. III. Evaluate the frequency and severity of the toxic effects associated with this therapy. IV. Assess the rate of resectability in patients who respond to therapy.\n\nOUTLINE: All patients undergo surgical placement of an indwelling central venous line. Patients receive fluorouracil IV by continuous infusion on days 1-28, leucovorin calcium IV on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin IV every 6 weeks starting on day 1. Treatment repeats every 6 weeks for 4 courses. Patients with a partial or complete response are reevaluated for possible surgical resection. Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks. Patients are followed every 6 months for 2 years, then annually until death.\n\nPROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically or cytologically proven stage II or III pancreatic adenocarcinoma Ductal adenocarcinoma Mucinous noncystic carcinoma Signet ring cell carcinoma Adenosquamous carcinoma Undifferentiated (anaplastic) carcinoma Mixed ductal-endocrine carcinoma Well differentiated adenocarcinoma Moderately well or poorly differentiated adenocarcinoma Undifferentiated ductal carcinoma Must have unresectable and localized disease Measurable or evaluable disease\n\nPATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Loss of no greater than 15% of actual body weight Oral intake of greater than 1,200 calories per day No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is currently in complete remission\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy for pancreatic cancer Surgery: At least 2 weeks since prior surgical bypass procedure and recovered'}, 'identificationModule': {'nctId': 'NCT00003018', 'briefTitle': 'S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients With Locally Advanced Unresected Pancreatic Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CDR0000065599'}, 'secondaryIdInfos': [{'id': 'S9700', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chemotherapy', 'description': 'dipyridamole: 75mg/dose, PO, Days 1-28 of 5 week cycle; fluorouracil: 200 mg/m\\^2/day, continuous IV, Days 1-28 of 5 week cycle; leucovorin calcium: 30 mg/m\\^2/day, IV, Days 1,8,15,22 of 5 week cycle; mitomycin C: 10 mg/m\\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)', 'interventionNames': ['Drug: dipyridamole', 'Drug: fluorouracil', 'Drug: leucovorin calcium', 'Drug: mitomycin C']}], 'interventions': [{'name': 'dipyridamole', 'type': 'DRUG', 'otherNames': ['Persantine', 'NSC-515776'], 'description': '75mg/dose, PO, Days 1-28 of 5 week cycle', 'armGroupLabels': ['Chemotherapy']}, {'name': 'fluorouracil', 'type': 'DRUG', 'otherNames': ['5-fluorouracil', '5-FU', 'NSC-19893'], 'description': '200 mg/m\\^2/day, continuous IV, Days 1-28 of 5 week cycle', 'armGroupLabels': ['Chemotherapy']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'otherNames': ['NSC-3590'], 'description': '30 mg/m\\^2/day, IV, Days 1,8,15,22 of 5 week cycle', 'armGroupLabels': ['Chemotherapy']}, {'name': 'mitomycin C', 'type': 'DRUG', 'otherNames': ['Mutamycin', 'NSC-26980'], 'description': '10 mg/m\\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)', 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'MBCCOP - University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Greater Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Phoenix (Hayden)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Little Rock (McClellan)', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90033-0800', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91010', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Beckman Research Institute, City of Hope', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94553', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Outpatient Clinic - 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