Everolimus and Vatalanib in Treating Patients With Advanced Solid Tumors

This is an interventional treatment trial for Gastrinoma Read More

Inclusion Criteria:

• Histologic proof of cancer that is now unresectable (solid tumors, excluding lymphoma)
• Ability to provide informed consent
• Willingness to return to Mayo Clinic Rochester for follow up
• Life expectancy >= 12 weeks
• Prior anti-VEGF therapy allowed
• Cohort IIA: Patients meeting other eligibility criteria, regardless of histopathologic diagnosis; tumor that is amenable to biopsy; willingness to provide blood specimens, undergo DCE-MRI, and undergo brachial artery ultrasound measurements as required by the protocol
• The following laboratory values obtained =< 14 days prior to registration:

Negative for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary protein =< 500 mg and measured creatinine clearance (CrCl) >= 50 mL/min from a 24-hour urine collection

• Cohort IIB: Patients meeting other eligibility criteria AND with pathologic diagnosis of metastatic kidney cancer, neuroendocrine carcinoma, melanoma, and NSCLC; willingness to provide blood specimens required and undergo brachial artery ultrasound measurements
• The following laboratory values obtained =< 14 days prior to registration:

ANC >= 1500/uL; Hgb >= 9 g/dL; PLT >= 100,000/uL; Total bilirubin =< 1.5 x upper limit of normal (ULN); AST =< 3 x ULN or AST =< 5 x ULN if liver involvement; Creatinine =< 1.5 x ULN; INR =< 1.4 (Cohort IIA only)

Exclusion Criteria:

• Any of the following prior therapies: Full field radiation therapy =<4 weeks prior to registration or limited field radiation therapy =< 2 weeks prior to registration; Radiation to >30% of bone marrow; Major surgery (i.e., laparotomy) =< 4 weeks prior to registration; Minor surgery =< 2 weeks prior to registration
• New York Heart Association classification III or IV
• Uncontrolled hypertension, labile hypertension or history of poor compliance with antihypertensive medication
• Active, bleeding diathesis or on any anticoagulant except patients receiving heparin for deep venous thrombosis prophylaxis (not treatment)
• CNS metastases or seizure disorder
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation
• Any concurrent severe and/or uncontrolled medical conditions which could compromise participation or pose as unnecessary risk to the patient in the study, including, but not limited, to the following: Unstable angina; Myocardial infarction =< 6 months prior to registration; Serious uncontrolled cardiac arrhythmia; Uncontrolled diabetes
• Any concurrent severe and/or uncontrolled medical conditions which could compromise participation or pose as unnecessary risk to the patient in the study, including, but not limited, to the following: Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung; QTc > 500 msec; Patients who require chronic treatment with PPI or H2 antagonist
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (i.e., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the tablets)
• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• Chemotherapy =< 3 weeks; Mitomycin C/nitrosoureas =< 6 weeks; Immunotherapy =< 2 weeks; Biologic therapy =< 2 weeks; Prior investigational therapy =< 4 weeks; Full field radiation therapy =< 4 weeks or limited field radiation therapy =< 2 weeks; Radiation to > 30% of bone marrow; Major surgery (i.e., laparotomy) =< 4 weeks; or Minor surgery =< 2 weeks prior to registration
• Any of the following: pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate barrier contraception
• Patients on whom DCE-MRI is contraindicated (e.g., presence of MRI-incompatible metallic implants or prosthetic heart valves, pacemakers, etc.) are ineligible
• ECOG performance status (PS) 3 or 4
• Treatment with medications listed in Appendix I for which no safer or more efficacious alternative is available
• Uncontrolled infection
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment