Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT00004103
Status:
COMPLETED
Last Update Posted:
2011-04-06
First Post:
1999-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005467', 'term': 'Floxuridine'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003857', 'term': 'Deoxyuridine'}, {'id': 'D014529', 'term': 'Uridine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '1999-12-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I gastric cancer', 'stage II gastric cancer', 'stage III gastric cancer', 'stage IV gastric cancer'], 'conditions': ['Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '16399443', 'type': 'RESULT', 'citation': 'Newman E, Potmesil M, Ryan T, Marcus S, Hiotis S, Yee H, Norwood B, Wendell M, Muggia F, Hochster H. Neoadjuvant chemotherapy, surgery, and adjuvant intraperitoneal chemotherapy in patients with locally advanced gastric or gastroesophageal junction carcinoma: a phase II study. Semin Oncol. 2005 Dec;32(6 Suppl 9):S97-100. doi: 10.1053/j.seminoncol.2005.06.002.'}]}, '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 and combining chemotherapy with surgery may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin.\n* Determine the rate of potentially curative surgery in patients receiving this regimen.\n* Determine the toxicity and tolerance of this regimen in these patients.\n\nOUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later.\n\nPatients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose.\n\nPatients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.\n\nPROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven, previously untreated gastric cancer\n\n * Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0)\n * No metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* SWOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 4000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9 g/dL\n\nHepatic:\n\n* Bilirubin less than 2 mg/dL\n* SGOT/SGPT no greater than 2 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 3 times ULN\n* PT, aPTT, and TT normal\n* No Gilbert's disease\n\nRenal:\n\n* BUN no greater than 30 mg/dL\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance greater than 60 mL/min\n\nCardiovascular:\n\n* No myocardial infarction within the past 3 months\n* No congestive heart failure requiring therapy\n\nOther:\n\n* No other invasive malignancy in the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix\n* No active or uncontrolled infection\n* HIV negative\n* No other severe concurrent disease\n* No psychiatric disorders that would preclude compliance\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy for gastric cancer\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy for gastric cancer\n\nSurgery:\n\n* No prior surgery for gastric cancer\n* No emergent need for surgery for gastrointestinal obstruction, perforation, or hemorrhage"}, 'identificationModule': {'nctId': 'NCT00004103', 'briefTitle': 'Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Phase II Study of Systemic Therapy With CPT-11 (Camptosar HCl) and Cisplatin in Patients With Advanced Gastric Cancer to be Followed by Surgical Resection and Postoperative Intraperitoneal Chemotherapy', 'orgStudyIdInfo': {'id': 'CDR0000067322'}, 'secondaryIdInfos': [{'id': 'P30CA016087', 'link': 'https://reporter.nih.gov/quickSearch/P30CA016087', 'type': 'NIH'}, {'id': 'NYU-9822'}, {'id': 'P-UPJOHN-647597196'}, {'id': 'NCI-G99-1594'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'floxuridine', 'type': 'DRUG'}, {'name': 'irinotecan hydrochloride', 'type': 'DRUG'}, {'name': 'adjuvant therapy', 'type': 'PROCEDURE'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Cancer Institute at New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Elliot Newman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}