Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00303732
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2006-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'C404768', 'term': 'vatalanib'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2006-03-15', 'studyFirstSubmitQcDate': '2006-03-15', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) of vatalanib and everolimus', 'timeFrame': 'Day 1 - 28', 'description': 'Patients were evaluated on Day 1,14 and 28 for dose limiting toxicities'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Duration of study treatment', 'description': 'Adverse events were assessed every 14 days for the length of the treatment period.'}, {'measure': 'Safety and tolerability at the MTD in patients with metastatic renal cell carcinoma (RCC)', 'timeFrame': 'Duration of study treatment', 'description': 'Patients were assessed for adverse events every 14 days while on study treatment'}], 'secondaryOutcomes': [{'measure': 'Non dose-limiting toxicity', 'timeFrame': 'Duration of study treatment', 'description': 'Patients were assessed every 14 days for non dose-limiting toxicity while on study treatment'}, {'measure': 'Pharmacokinetics', 'timeFrame': 'Day 14 Cycle 1, Day 1 Cycle 2', 'description': 'Blood was drawn for PK assessment on Day 14 of Cycle 1 and Day 1 of Cycle 2'}, {'measure': 'Changes in the phosphorylation status of S6K protein in peripheral blood mononuclear cells', 'timeFrame': 'Day 1 and 28', 'description': 'Samples were collected on Day 1 and at Day 28 of Cycle 1'}, {'measure': 'Clinical response in patients with metastatic RCC', 'timeFrame': 'Duration of treatment', 'description': 'patients underwent restaging studies every 2 cycles while on treatment for evidence of disease response'}, {'measure': 'Overall survival of patients with RCC', 'timeFrame': 'Until death'}, {'measure': 'Time to progression of patients with RCC', 'timeFrame': 'Duration of study treatment', 'description': 'Patients were followed for evidence of disease progression as long as they remained on study drug.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific', 'recurrent renal cell cancer', 'stage IV renal cell cancer'], 'conditions': ['Kidney Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Speca JC, Mears AL, Creel PA, et al.: Phase I study of PTK787/ZK222584 (PTK/ZK) and RAD001 for patients with advanced solid tumors and dose expansion in renal cell carcinoma patients. [Abstract] J Clin Oncol 25 (Suppl 18): A-5039, 244s, 2007.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and 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 vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose (MTD) of vatalanib and everolimus in patients with advanced solid tumors.\n* Determine the safety and tolerability of vatalanib and everolimus in patients with advanced solid tumors.\n* Evaluate the safety and tolerability of vatalanib and everolimus at the MTD in patients with metastatic renal cell carcinoma (RCC).\n\nSecondary\n\n* Describe the non dose-limiting toxic effects associated with vatalanib and everolimus.\n* Describe the pharmacokinetics of vatalanib and everolimus in patients with advanced solid tumors.\n* Determine the functional extent of mTOR inhibition by changes in the phosphorylation status of S6K protein in peripheral blood mononuclear cells in patients treated with vatalanib and everolimus.\n* Describe any clinical responses seen in patients with metastatic RCC in a dose-expansion cohort treated at the MTD.\n* Observe overall survival of RCC patients treated with vatalanib and everolimus.\n* Determine the time to progression of patients with RCC treated with vatalanib and everolimus.\n\nOUTLINE: This is a phase I dose-escalation study followed by a phase Ib study.\n\n* Phase I (solid tumors): Patients receive oral vatalanib on days 1-28 and oral everolimus on days 15-28 during course 1 and on days 1-28 during all subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of vatalanib and everolimus 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\n* Phase Ib (renal cell carcinoma only): Patients receive oral vatalanib and oral everolimus at the MTD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed every 6 months.\n\nPROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed solid tumor with radiographic evidence of metastatic disease\n\n * No standard therapy exists (phase I)\n * Unresectable or metastatic renal cell carcinoma (phase Ib)\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 70-100%\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Hemoglobin ≥ 9 g/dL\n* AST or ALT ≤ 2.5 times upper limit of normal (ULN)\n* Total cholesterol \\< 300 mg/dL\n* Triglycerides \\< 350 mg/dL\n* Bilirubin ≤ 1.5 times ULN\n* Creatinine ≤ 1.5 times ULN OR creatinine clearance \\> 40 mL/min\n* Negative proteinuria by dip stick OR total urinary protein ≤ 500 mg\n* No uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with antihypertensive regimen\n* No unstable angina pectoris\n* No symptomatic congestive heart failure (New York Heart Association class III or IV heart disease)\n* No uncontrolled serious cardiac arrhythmia (symptomatic supraventricular tachycardia or any ventricular tachycardia/fibrillation)\n* No myocardial infarction in the past 6 months\n* No uncontrolled diabetes\n* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung\n* No active or uncontrolled infection\n* No uncontrolled hyperlipidemia\n* No chronic renal disease\n* No acute or chronic liver disease (e.g., hepatitis or cirrhosis)\n* No impaired gastrointestinal (GI) function OR GI disease that may significantly alter the absorption of vatalanib or everolimus, including any of the following:\n\n * Ulcerative disease\n * Uncontrolled nausea and vomiting with solid food\n * Watery diarrhea \\> 5 times daily\n * Malabsorption syndrome\n * Bowel obstruction\n * Inability to swallow the tablets\n* No confirmed HIV infection\n* Not pregnant\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other concurrent severe and/or uncontrolled medical condition that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from prior therapy\n* No prior antivascular endothelial growth factor therapy\n* More than 4 weeks since prior major surgery\\* (laparotomy)\n* More than 2 weeks since prior minor surgery\\*\n* More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)\n* More than 6 weeks since prior antibody therapy\n* More than 2 weeks since prior biologic/immunotherapy\n* More than 2 weeks since prior limited-field radiotherapy\n* More than 4 weeks since prior full-field radiotherapy\n* More than 4 weeks since prior investigational agents\n* Prior transfusions allowed provided blood counts are stable for \\> 2 weeks\n* Concurrent epoetin alfa allowed\n* No concurrent warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system\n\n * Heparin and low molecular weight heparin allowed NOTE: \\*Insertion of a vascular access device is not considered major or minor surgery'}, 'identificationModule': {'nctId': 'NCT00303732', 'acronym': 'PTK/RAD', 'briefTitle': 'Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'PTK787/ZK222584 and RAD001 for Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'Pro00012347'}, 'secondaryIdInfos': [{'id': 'DUMC-6626-04-12R0', 'type': 'OTHER', 'domain': 'Duke IRB legacy number'}, {'id': 'CDR0000454988', 'type': 'OTHER', 'domain': 'National Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTK787, RAD001', 'description': 'PTK787 (vatalinib) 1000 mg daily, RAD001 (everolimus) 5 mg daily', 'interventionNames': ['Drug: RAD001 (everolimus)', 'Drug: PTK787 (vatalanib)']}], 'interventions': [{'name': 'RAD001 (everolimus)', 'type': 'DRUG', 'otherNames': ['Afinitor'], 'armGroupLabels': ['PTK787, RAD001']}, {'name': 'PTK787 (vatalanib)', 'type': 'DRUG', 'armGroupLabels': ['PTK787, RAD001']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Daniel J. George, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daniel George, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Daniel George, MD', 'investigatorAffiliation': 'Duke University'}}}}