Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT00062257
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2003-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Irofulven in Treating Patients With Recurrent or Metastatic Gastric 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': 'C102714', 'term': 'irofulven'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-03', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2003-06-05', 'studyFirstSubmitQcDate': '2003-06-05', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-06-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent gastric cancer', 'stage IV gastric cancer', 'adenocarcinoma of the stomach'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.\n* Determine the toxicity profile of this drug in these patients.\n* Determine the overall survival of patients treated with this drug.\n\nOUTLINE: This is a non-randomized, open-label, multicenter study.\n\nPatients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed gastric adenocarcinoma\n\n * Recurrent or metastatic disease\n * Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction\n* Measurable disease\n\n * At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 3 months\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* No active disseminated intravascular coagulation\n\nHepatic\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases)\n* Alkaline phosphatase no greater than 5 times ULN\n\nRenal\n\n* Creatinine no greater than 1.5 times ULN\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 prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven\n* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer\n* No other uncontrolled concurrent illness that would preclude study participation\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n* Must have central or peripherally inserted central catheter\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa\n\nChemotherapy\n\n* No prior chemotherapy for recurrent or metastatic disease\n* Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy and recovered\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other concurrent investigational or commercial agents or therapies for the malignancy\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00062257', 'briefTitle': 'Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer', 'orgStudyIdInfo': {'id': 'CTRG-G15/02'}, 'secondaryIdInfos': [{'id': 'CDR0000304669', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-6041'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'irofulven', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Cancer Centre at Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Shatin, New Territories', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital'}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Cancer Institute at National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Johns Hopkins - Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169610', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Cancer Centre - Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei Cancer Center at Yonsei University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Winnie Yeo', 'role': 'STUDY_CHAIR', 'affiliation': 'Prince of Wales Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Therapeutics Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}