Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-30 @ 2:45 PM
Study NCT ID:
NCT00004257
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2000-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-25', 'studyFirstSubmitDate': '2000-01-28', 'studyFirstSubmitQcDate': '2003-04-17', 'lastUpdatePostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage I esophageal cancer', 'stage II esophageal cancer', 'stage III esophageal cancer', 'squamous cell carcinoma of the esophagus', 'adenocarcinoma of the esophagus'], 'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Smith PF, Booker B, Pendyala L, et al.: Pharmacokinetic modeling of oxaliplatin with and without 5-FU and radiation. [Abstract] Proc Am Assoc Cancer Res 42: A-2913, 542, 2001.'}, {'type': 'RESULT', 'citation': 'Khushalani N, Nava H, Leichman CG, et al.: A phase I study of oxaliplatin in combination with continous infusion 5-fluorouracil and radiation in esophagus cancer. [Abstract] Proc Am Assoc Cancer Res 42: A-3751, 697, 2001.'}, {'type': 'RESULT', 'citation': 'Pendyala L, Leichman CG, Clark K, et al.: Oxaliplatin, 5-fluorouracil, and radiation in cancer of the esophagus: a pharmacokinetic (PK)/molecular correlates study. [Abstract] Proc Am Assoc Cancer Res 42: A-3347, 623, 2001.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when given in combination with continuous-infusion fluorouracil and radiotherapy in patients with primary cancer of the thoracic esophagus or gastroesophageal junction.\n* Determine the pharmacokinetics of this regimen in this patient population.\n* Assess somatic p53 mutations in cancer of the esophagus and determine their relation to therapeutic response induced by this regimen.\n* Assess, in a preliminary manner, the efficacy of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil.\n\nPatients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously on days 8-42. Patients also undergo radiotherapy once daily, 5 days a week, for 6 weeks beginning on day 8.\n\nPatients without evidence of distant disease or unresectable local regional invasion undergo esophageal resection between days 63-70 (within 3-4 weeks after completion of chemoradiotherapy). Patients then receive oxaliplatin as above on days 105, 119, and 133 and fluorouracil as above on days 105-147.\n\nCohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil 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\nPatients are followed every 4 weeks.\n\nPROJECTED ACCRUAL: A total of 56 patients will be accrued for this study within approximately 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or gastroesophageal (GE) junction\n\n * Stage I-III\n * Bronchoscopy with biopsy and cytology required if primary esophageal cancer is less than 26 cm from incisors\n* No disease outside esophagus and peri-esophageal soft tissue\n* GE junction tumors must be confined to no greater than 2 cm into the gastric cardia\n* Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by physical examination\n\n * Nodes 1.5 cm or greater or palpable by physical examination must be confirmed to be nonmalignant by biopsy\n* Subdiaphragmatic lymph nodes at stations 15-20 must be no greater than 1.5 cm\n* No recurrent disease\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/mm3\n* Granulocyte count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin normal\n* AST/ALT no greater than 2.5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2.5 times ULN\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* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No grade 2 peripheral neuropathy\n* No history of allergy to platinum compounds\n* No history of allergy to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy\n* No other concurrent uncontrolled illness\n* No ongoing or active infection\n* No other malignancy within the past 5 years\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No colony-stimulating factor therapy during first study course\n\nChemotherapy:\n\n* No prior chemotherapy for esophageal cancer\n* At least 4 weeks since other prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy for esophageal cancer\n* At least 4 weeks since other prior radiotherapy\n\nSurgery:\n\n* No prior resection or attempted resection of esophageal cancer\n\nOther:\n\n* No other concurrent investigational drugs\n* No other concurrent commercial agents or therapies for esophageal cancer\n* No concurrent highly active antiretroviral agents (HAART) for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00004257', 'briefTitle': 'Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer', 'orgStudyIdInfo': {'id': 'CDR0000067504'}, 'secondaryIdInfos': [{'id': 'ALB-RPCI-DS-99-08'}, {'id': 'RPCI-DS-99-08'}, {'id': 'NCI-T99-0061'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fluorouracil', 'type': 'DRUG'}, {'name': 'oxaliplatin', 'type': 'DRUG'}, {'name': 'conventional surgery', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Lawrence P. Leichman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Albany Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}