Pegylated Liposomal Doxorubicin Hydrochloride, Bevacizumab, and Temsirolimus in Treating Patients With Advanced Cancer

Inclusion Criteria

• Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least three months
• All patients must have an estimated life expectancy of at least 12 weeks
• Patients must have measurable or evaluable disease
• Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study; six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosourea); five half-lives will be required for biologic/targeted therapies with short (< 24 hour) half-lives and pharmacodynamic effects; patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Absolute neutrophil count >= 1,500/mL
• Platelets >= 100,000/mL
• Creatinine =< 3 x upper limit of normal (ULN)
• Total bilirubin =< 2.0
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5 x ULN; in patients with significant liver disease and chronically elevated liver transaminases, ALT may be elevated as high as 8 x ULN
• Cardiac ejection fraction >= 50% without evidence of congestive heart failure (CHF)
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
• Ability to understand and the willingness to sign a written informed consent document
• Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance treatment for prostate cancer

Exclusion Criteria

• Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
• Poorly controlled systemic vascular hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
• Patients with clinically significant cardiovascular disease: history of cerebrovascular accident (CVA) within 6 months, myocardial infarction or unstable angina within 6 months, unstable angina pectoris, New York Heart Association class CHF score II
• Prior cumulative doxorubicin dose > 300 mg/m^2
• Pregnant or lactating women
• History of hypersensitivity to doxil, doxorubicin, hydrochloride (HCL), temsirolimus or its metabolites (including sirolimus), polysorbate 80, bevacizumab or murine products
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study
• Inability to swallow tablets for everolimus arm