Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT00017212
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2001-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DX-8951f in Treating Patients With Metastatic Stomach Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'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': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C095887', 'term': 'exatecan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage III gastric cancer', 'stage IV gastric cancer', 'recurrent gastric cancer', 'stage III esophageal cancer', 'stage IV esophageal cancer', 'recurrent esophageal cancer', 'adenocarcinoma of the stomach', 'adenocarcinoma of the esophagus'], 'conditions': ['Esophageal Cancer', 'Gastric Cancer']}, 'referencesModule': {'references': [{'pmid': '16133799', 'type': 'RESULT', 'citation': 'Ajani JA, Takimoto C, Becerra CR, Silva A, Baez L, Cohn A, Major P, Kamida M, Feit K, De Jager R. A phase II clinical and pharmacokinetic study of intravenous exatecan mesylate (DX-8951f) in patients with untreated metastatic gastric cancer. Invest New Drugs. 2005 Oct;23(5):479-84. doi: 10.1007/s10637-005-2907-z.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have metastatic stomach cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the objective response rate of patients with previously untreated metastatic gastric cancer treated with exatecan mesylate (DX-8951f).\n* Determine the time to tumor progression in this patient population when treated with this drug.\n* Determine the survival at 6 and 12 months in this patient population when treated with this drug.\n* Determine the quantitative and qualitative toxic effects of this drug in this patient population.\n* Determine the pharmacokinetics of this drug in the plasma of these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive exatecan mesylate (DX-8951f) IV over 30 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed gastric or gastroesophageal adenocarcinoma\n\n * Lymph node involvement and/or distant metastasis\n* No squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the stomach\n* Measurable disease with indicator lesions outside the field of prior radiotherapy\n\n * At least 20 mm by conventional scan OR\n * At least 10 mm by spiral CT scan\n * Nonmeasurable lesions include the following:\n\n * Primary tumor\n * Bone lesions\n * Leptomeningeal disease\n * Ascites\n * Pleural/pericardial effusion\n * Inflammatory breast disease\n * Lymphangitis cutis/pulmonitis\n * Cystic lesions\n * Abdominal masses not confirmed and followed by imaging techniques\n* No prior treatment for locally advanced or metastatic disease\n\n * Prior adjuvant treatment allowed if disease recurrence noted at least 6 months after completion of adjuvant treatment\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* At least 12 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n* Hemoglobin at least 9.0 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n* AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)\n* Albumin at least 2.8 g/dL\n* PT or INR no greater than 1.5 times ULN (coumadin independent)\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No active congestive heart failure\n* No uncontrolled angina\n* No myocardial infarction within the past 6 months\n\nOther:\n\n* No concurrent serious infection\n* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No overt psychosis, mental disability, or incompetence that would preclude informed consent\n* No other life-threatening illness\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n\nBiologic therapy:\n\n* No concurrent anti-cancer biologic therapy\n* No concurrent prophylactic colony stimulating factors during first course of therapy\n\nChemotherapy:\n\n* Recovered from prior adjuvant chemotherapy\n* No other concurrent anti-cancer chemotherapy\n* No other concurrent anti-cancer cytotoxic therapy\n\nEndocrine therapy:\n\n* Concurrent megestrol for appetite stimulation allowed\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy and recovered\n* No prior wide-field radiotherapy to more than 25% of bone marrow\n* No concurrent anti-cancer radiotherapy\n\nSurgery:\n\n* At least 4 weeks since prior major surgery and recovered\n* No concurrent anti-cancer surgery\n\nOther:\n\n* No other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study'}, 'identificationModule': {'nctId': 'NCT00017212', 'briefTitle': 'DX-8951f in Treating Patients With Metastatic Stomach Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer', 'orgStudyIdInfo': {'id': 'CDR0000068663'}, 'secondaryIdInfos': [{'id': 'DAIICHI-8951A-PRT028'}, {'id': 'SACI-IDD-00-27'}, {'id': 'UTHSC-0015011134'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'exatecan mesylate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Shores Medical Group', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '75235-9154', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Cancer Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229-3264', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy and Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-Hamilton Regional Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Robert L. DeJager, MD, FACP', 'role': 'STUDY_CHAIR', 'affiliation': 'Daiichi Sankyo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}