Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT00005860
Status:
COMPLETED
Last Update Posted:
2011-04-26
First Post:
2000-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D015408', 'term': 'Gastrinoma'}, {'id': 'D005706', 'term': 'Gallbladder Neoplasms'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D007340', 'term': 'Insulinoma'}, {'id': 'D018273', 'term': 'Carcinoma, Islet Cell'}, {'id': 'D003969', 'term': 'Vipoma'}, {'id': 'D013005', 'term': 'Somatostatinoma'}, {'id': 'D005935', 'term': 'Glucagonoma'}, {'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D001063', 'term': 'Appendiceal Neoplasms'}, {'id': 'D011553', 'term': 'Pseudomyxoma Peritonei'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D009382', 'term': 'Neoplasms, Unknown Primary'}, {'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D002430', 'term': 'Cecal Neoplasms'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D002288', 'term': 'Adenocarcinoma, Mucinous'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005467', 'term': 'Floxuridine'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'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': '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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-05', 'lastUpdateSubmitDate': '2011-04-23', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2004-04-01', 'lastUpdatePostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV gastric cancer', 'recurrent gastric cancer', 'recurrent pancreatic cancer', 'recurrent colon cancer', 'regional neuroblastoma', 'stage 4S neuroblastoma', 'recurrent neuroblastoma', 'regional gastrointestinal carcinoid tumor', 'metastatic gastrointestinal carcinoid tumor', 'recurrent gastrointestinal carcinoid tumor', 'advanced adult primary liver cancer', 'recurrent adult primary liver cancer', 'gastrinoma', 'small intestine adenocarcinoma', 'small intestine lymphoma', 'small intestine leiomyosarcoma', 'unresectable gallbladder cancer', 'recurrent gallbladder cancer', 'unresectable extrahepatic bile duct cancer', 'recurrent extrahepatic bile duct cancer', 'recurrent small intestine cancer', 'insulinoma', 'recurrent islet cell carcinoma', 'WDHA syndrome', 'somatostatinoma', 'pancreatic polypeptide tumor', 'glucagonoma', 'regional pheochromocytoma', 'metastatic pheochromocytoma', 'recurrent pheochromocytoma', 'extragonadal germ cell tumor', 'liver metastases', 'malignant ascites', 'newly diagnosed carcinoma of unknown primary', 'carcinoma of the appendix', 'pseudomyxoma peritonei', 'fallopian tube cancer', 'primary peritoneal cavity cancer', 'recurrent carcinoma of unknown primary', 'gastrointestinal stromal tumor', 'stage IV pancreatic cancer'], 'conditions': ['Cancer']}, '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.\n\nPURPOSE: Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine and leucovorin in treating patients who have metastatic cancer of the peritoneum.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose of intraperitoneal oxaliplatin with or without intraperitoneal floxuridine and leucovorin calcium in patients with metastatic cancer confined to the peritoneal cavity.\n* Determine dose limiting and nondose limiting toxicities and pharmacokinetics of these treatment regimens in this patient population.\n\nOUTLINE: This is a dose escalation study of oxaliplatin.\n\nPatients receive intraperitoneal (IP) oxaliplatin over 1 hour on day 1 every 2 weeks for 2 courses.\n\nBeginning at course 3, patients receive oxaliplatin with floxuridine and leucovorin calcium IP on day 1 and floxuridine and leucovorin calcium IP alone on days 2 and 3. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete surgical resection of disease receive a total of 6 courses of combination chemotherapy.\n\nCohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.\n\nPROJECTED ACCRUAL: A total of 3-40 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed metastatic or unresectable cancer largely confined to the peritoneal cavity\n\n * Fully resected and/or electrocauterized metastatic disease involving the peritoneum (stage IV, no residual disease) allowed\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 3,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin normal\n* SGOT/SGPT no greater than 2.5 times upper limit of normal\n\nRenal:\n\n* Creatinine normal OR\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular:\n\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n\nOther:\n\n* No history of allergy to platinum compounds or antiemetics that would preclude study\n* No other uncontrolled illness (e.g., active infection)\n* No evidence of neuropathy\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* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* No other concurrent investigational agents\n* No concurrent antiretroviral therapy (HAART)'}, 'identificationModule': {'nctId': 'NCT00005860', 'briefTitle': 'Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study of Intraperitoneal Oxaliplatin Alone and in Combination With Intraperitoneal Floxuridine and Leucovorin in Patients With Advanced Metastatic Cancer Confined to the Peritoneal Cavity', 'orgStudyIdInfo': {'id': 'CDR0000067890'}, 'secondaryIdInfos': [{'id': 'MSKCC-99100'}, {'id': 'NCI-T99-0107'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'floxuridine', 'type': 'DRUG'}, {'name': 'leucovorin calcium', 'type': 'DRUG'}, {'name': 'oxaliplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Leonard B. Saltz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}