Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00098527
Status:
TERMINATED
Last Update Posted:
2013-07-02
First Post:
2004-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'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': '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': 'C087123', 'term': 'romidepsin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-01', 'studyFirstSubmitDate': '2004-12-07', 'studyFirstSubmitQcDate': '2004-12-07', 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic response rate (complete response & partial response)', 'timeFrame': 'Not Provided'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS) according to RECIST', 'timeFrame': 'Up to more than 6 months', 'description': 'The median time to progression and median PFS for all eligible patients, along with their CIs, will be reported. The Kaplan-Meier analysis approach may be used to summarize these time-to-event endpoints.'}, {'measure': 'Frequency of treatment related grade 1-4 toxicities and cardiac toxicities as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0', 'timeFrame': 'Up to 12 months'}, {'measure': 'Correlation of changes in gene expression profile in dermal granulation tissue pre- and post-treatment with gene expression profile', 'timeFrame': 'Not Provided'}, {'measure': 'Correlation of wound vascular scores pre- and post-treatment with gene/protein changes', 'timeFrame': 'Not Provided'}, {'measure': 'Toxicity', 'timeFrame': 'Not Provided'}, {'measure': 'Changes in gene expression profile', 'timeFrame': 'At pre- and post-treatment'}, {'measure': 'Changes in levels of p21 and thymidine kinase expression, and tubulin acetylation using Western blotting', 'timeFrame': 'From baseline to 3 weeks'}, {'measure': 'Changes in gene expression profile in dermal granulation tissue', 'timeFrame': 'From baseline to up to 3 weeks'}, {'measure': 'Change in plasma and urine TGFB levels', 'timeFrame': 'At pre-and post-treatment'}]}, 'conditionsModule': {'conditions': ['Adenocarcinoma of the Esophagus', 'Adenocarcinoma of the Stomach', 'Recurrent Esophageal Cancer', 'Recurrent Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying how well FR901228 works in treating patients with refractory stomach cancer or gastroesophageal junction. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for their growth.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the radiographic response rate (complete response and partial response) in patients with refractory adenocarcinoma of the stomach or gastroesophageal junction treated with FR901228 (depsipeptide).\n\nSECONDARY OBJECTIVES:\n\nI. Determine the median time to progression and progression-free survival of patients treated with this drug.\n\nII. Determine the grade 3 and 4 toxic effects of this drug in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 13-20 patients will be accrued for this study within 6.5-10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction\n* Measurable disease\n\n * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan\n* Refractory\\* to at least 1, but no more than 3, of the following first-line agents:\n\n * Fluoropyrimidine (e.g., capecitabine or fluorouracil)\n * Taxane (e.g., paclitaxel or docetaxel)\n * Platinum (e.g., carboplatin, cisplatin, or oxaliplatin)\n* No known active brain metastases\n\n * Treated brain metastases allowed provided metastases are stable off steroids for ≥ 30 days\n* Performance status - ECOG 0-2\n* Performance status - Karnofsky 60-100%\n* At least 3 months\n* WBC ≥ 3,000/mm\\^3\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n* AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)\n* Creatinine clearance ≥ 50 mL/min\n* No congestive heart failure\n* No New York Heart Association class III or IV heart disease\n* No myocardial infarction within the past 6 months\n* No ventricular arrhythmias requiring medication\n* No angioplasty or vascular stenting within the past 3 months\n* No unstable angina\n* No left ventricular hypertrophy by EKG\n* No known history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)\n* QTc \\< 500 msec\n* LVEF \\> 40% by MUGA or echocardiogram\n* No other significant cardiac disease\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Potassium ≥ 4.0 mmol/L (stable level with no change in supplementation within the past 2 weeks)\n* Magnesium ≥ 2.0 mg/dL (stable level with no change in supplementation within the past 2 weeks)\n* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n* No other uncontrolled illness\n* Prior biological agents allowed\n* No concurrent prophylactic filgrastim (G-CSF)\n* No concurrent biologic therapy\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n* No other concurrent chemotherapy\n* More than 4 weeks since prior radiotherapy and recovered\n* No concurrent radiotherapy\n* Prior targeted agents allowed\n* No other prior or concurrent cytotoxic agents\n* No other concurrent investigational agents\n* No other concurrent anticancer therapy\n* No concurrent medications causing QTc prolongation\n* No concurrent potassium supplementation \\> 40 mg/day or magnesium supplementation \\> 1 g/week\n* No concurrent hydrochlorothiazide\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00098527', 'briefTitle': 'FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers', 'orgStudyIdInfo': {'id': 'NCI-2012-02637'}, 'secondaryIdInfos': [{'id': '6075-04-7R0'}, {'id': 'DUMC-6075-04-7R0'}, {'id': 'CDR0000398177'}, {'id': 'NCI-6351'}, {'id': 'U01CA099118', 'link': 'https://reporter.nih.gov/quickSearch/U01CA099118', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (romidepsin)', 'description': 'Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: romidepsin', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'romidepsin', 'type': 'DRUG', 'otherNames': ['FK228', 'FR901228', 'Istodax'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (romidepsin)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (romidepsin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Herbert Hurwitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}