Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel George, MD
• Collaborator: Novartis
• Treatments: Everolimus; Sirolimus; Vatalanib

Criteria

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