Status:
COMPLETED
Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Daniel George, MD
Collaborating Sponsors:
Novartis
Conditions:
Kidney Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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. PURPOSE: This phase I trial is s...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of vatalanib and everolimus in patients with advanced solid tumors. * Determine the safety and tolerability of vatalanib and everolim...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor with radiographic evidence of metastatic disease
- No standard therapy exists (phase I)
- Unresectable or metastatic renal cell carcinoma (phase Ib)
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- AST or ALT ≤ 2.5 times upper limit of normal (ULN)
- Total cholesterol \< 300 mg/dL
- Triglycerides \< 350 mg/dL
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN OR creatinine clearance \> 40 mL/min
- Negative proteinuria by dip stick OR total urinary protein ≤ 500 mg
- No uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with antihypertensive regimen
- No unstable angina pectoris
- No symptomatic congestive heart failure (New York Heart Association class III or IV heart disease)
- No uncontrolled serious cardiac arrhythmia (symptomatic supraventricular tachycardia or any ventricular tachycardia/fibrillation)
- No myocardial infarction in the past 6 months
- No uncontrolled diabetes
- No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
- No active or uncontrolled infection
- No uncontrolled hyperlipidemia
- No chronic renal disease
- No acute or chronic liver disease (e.g., hepatitis or cirrhosis)
- No impaired gastrointestinal (GI) function OR GI disease that may significantly alter the absorption of vatalanib or everolimus, including any of the following:
- Ulcerative disease
- Uncontrolled nausea and vomiting with solid food
- Watery diarrhea \> 5 times daily
- Malabsorption syndrome
- Bowel obstruction
- Inability to swallow the tablets
- No confirmed HIV infection
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent severe and/or uncontrolled medical condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- No prior antivascular endothelial growth factor therapy
- More than 4 weeks since prior major surgery\* (laparotomy)
- More than 2 weeks since prior minor surgery\*
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
- More than 6 weeks since prior antibody therapy
- More than 2 weeks since prior biologic/immunotherapy
- More than 2 weeks since prior limited-field radiotherapy
- More than 4 weeks since prior full-field radiotherapy
- More than 4 weeks since prior investigational agents
- Prior transfusions allowed provided blood counts are stable for \> 2 weeks
- Concurrent epoetin alfa allowed
- No concurrent warfarin or similar oral anticoagulants that are metabolized by the cytochrome P450 system
- Heparin and low molecular weight heparin allowed NOTE: \*Insertion of a vascular access device is not considered major or minor surgery
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00303732
Start Date
December 1 2004
End Date
August 1 2012
Last Update
March 3 2016
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710