Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-03-29 @ 9:02 PM
Study NCT ID:
NCT00573404
Status:
TERMINATED
Last Update Posted:
2011-11-16
First Post:
2007-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-12', 'studyFirstSubmitDate': '2007-12-13', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose of imatinib mesylate in combination with sunitinib malate', 'timeFrame': 'at 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Toxicity profile as assessed by NCI CTCAE v3.0', 'timeFrame': 'every 6 weeks'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'days 15 & 43'}, {'measure': 'Preliminary data on anti-tumor activity of these drugs as assessed by RECIST', 'timeFrame': '18 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastrointestinal stromal tumor'], 'conditions': ['Gastrointestinal Stromal Tumor']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Imatinib mesylate and sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate given together with sunitinib in treating patients with gastrointestinal stromal tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine the maximum tolerated dose of imatinib mesylate in combination with sunitinib malate in patients with gastrointestinal stromal tumors.\n* To determine the toxicity of this regimen in these patients.\n* To determine the antitumor activity in patients treated with this regimen.\n\nOUTLINE: This is a dose-escalation study of imatinib mesylate.\n\nPatients receive oral sunitinib malate once daily on days 1-14 in course 1 and on days 1-42 in all subsequent courses. Beginning in course 2, patients also receive oral imatinib mesylate once or twice daily on days 1-42. Courses repeat every 6 weeks in the absence of unacceptable toxicity.\n\nBlood samples are collected on day 15 and day 43 for pharmacokinetics.\n\nAfter completion of study treatment, patients are followed every 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Biopsy proven gastrointestinal stromal tumor\n* Patients previously treated with imatinib mesylate must have documented progression of disease\n\n * Untreated disease allowed\n* Must have ≥ 1 measurable lesion by RECIST\n* No history of or known brain metastases, spinal cord compression,carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* ANC ≥ 1,500/μL\n* Hemoglobin ≥ 9.0 g/dL\n* Platelet count ≥ 150,000/μL\n* Total serum bilirubin ≤ 2.0 mg/dL\n* Serum calcium ≤ 12.0 mg/dL\n* Serum creatinine ≤ 1.8 mg/dL\n* AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver function abnormalities are due to underlying malignancy)\n* Able to take oral medications\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No grade 3 hemorrhage within the past 4 weeks\n* No myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism within the past 6 months\n* No ongoing cardiac dysrhythmias ≥ grade 2\n* No prolonged QTc interval on baseline EKG\n* No hypertension that cannot be controlled by medications (BP \\> 150/100 mm Hg, despite medical therapy)\n* No pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication\n* No known HIV or AIDS-related illness or other active infection\n* No other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, preclude study entry\n* No malabsorption syndrome\n* No prior intolerance of imatinib mesylate or toxicity necessitating dose modification\n* No prior intolerance of sunitinib malate or toxicity necessitating dose modification\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedures\n* No major surgery or radiotherapy within the past 4 weeks\n* No concurrent treatment on another clinical trial, except supportive care trials or non-treatment trials (e.g., quality of life)\n* No concurrent ketoconazole and other agents known to induce CYP3A4\n* No concurrent theophylline or phenobarbital and/or other agents metabolized by the cytochrome P450 system\n* No ongoing therapeutic doses of coumadin, except low-dose oral coumadin up to 2 mg once daily for thrombosis prophylaxis\n* No concurrent Hypericum perforatum (St. John's wort) or other herbal medications"}, 'identificationModule': {'nctId': 'NCT00573404', 'briefTitle': 'Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors', 'nctIdAliases': ['NCT00495001'], 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors', 'orgStudyIdInfo': {'id': 'VICC GI 0621'}, 'secondaryIdInfos': [{'id': 'P30CA068485', 'link': 'https://reporter.nih.gov/quickSearch/P30CA068485', 'type': 'NIH'}, {'id': 'VU-VICC-GI-0621'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Intervention', 'interventionNames': ['Drug: imatinib mesylate', 'Drug: sunitinib malate', 'Other: pharmacological study']}], 'interventions': [{'name': 'imatinib mesylate', 'type': 'DRUG', 'otherNames': ['None noted'], 'description': 'will start at 200 mg daily and will be escalated up to 400 mg bid.If the 400 mg bid dose is tolerated, no further dose escalation will be performed. In the case of excessive toxicity on the starting dose, the option for de-escalation is provided. Sunitinib will start at 25 mg daily and if tolerated, will be escalated to 37.5 mg daily for subsequent dose levels.', 'armGroupLabels': ['Therapeutic Intervention']}, {'name': 'sunitinib malate', 'type': 'DRUG', 'otherNames': ['none noted'], 'armGroupLabels': ['Therapeutic Intervention']}, {'name': 'pharmacological study', 'type': 'OTHER', 'otherNames': ['Not noted'], 'armGroupLabels': ['Therapeutic Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center - Cool Springs', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37064', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center at Franklin', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-6838', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jordan D. Berlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}, {'name': 'Charles D. Blanke, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}, {'name': 'Emily Chan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine; Clinical Director, GI Oncology Program; Director, Phase I Program; Medical Director, Clinical Trials Shared Resources; Medical Oncologist', 'investigatorFullName': 'Jordan Berlin', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}