Rapamycin Plus Bevacizumab in Advanced Cancers

Exclusion Criteria

• •Prior treatment with both bevacizumab and an mTOR inhibitor is not allowed. Prior treatment with both bevacizumab OR mTOR inhibitor (including rapamycin) is allowed. Patients who had a grade 3 or greater side effect with either bevacizumab or an mTOR inhibitor cannot take part in this study.
• •Chemotherapy or Immunotherapy within the 4 weeks of study start
• •Radiotherapy within 14 days of study start
• •Cannot be receiving any other investigational drugs or any other cancer treatments while on study (with the exception of androgen ablating agents for patients with prostate cancer).
• •Patients with squamous non-small cell lung cancer (NSCLC)
• •Patients with lung cancer or lung metastases:
• •* on full dose anticoagulation
• •* taking 325mg aspirin per day
• •* on non-steroidal anti-inflammatory agents
• •HIV positive patients receiving combination anti-retroviral therapy are excluded due to potential for serious infections while taking marrow suppressing agents
• •Ongoing illness or medical exclusions, including but not limited to:
• •* active or ongoing infection
• •* symptomatic congestive heart failure
• •* uncontrolled hypertension despite optimal medical management
• •* cardiac arrhythmia except paroxysmal atrial fibrillation
• •* psychiatric illness/social situations that would limit compliance with study requirements
• •* history of organ allograft, bone marrow or peripheral blood stem cell transplant
• •* known or suspect allergy to bevacizumab or rapamycin
• •* seizure disorder treated with steroid or anticonvulsant therapy
• •* thrombotic or embolic events within 6 months of starting study
• •* pulmonary hemorrhage/bleeding within 12 weeks of starting study (grade 3 event within 4 weeks of first dose of drug). Patients with a history of pulmonary hemorrhage/bleeding cannot be on full dose anticoagulation.
• •* pulmonary fibrosis or interstitial lung disease
• •* serious non-healing wound, ulcer or bone fracture
• •* Major surgery, open biopsy or a traumatic injury within 4 weeks of starting study drug
• •* anticipated need for major surgery while on-study
• •* current use of any herbal supplements or rifampin (rifampicin)
• •* prior history of hypertensive crisis or hypertensive encephalopathy
• •* history of myocardial infarction or unstable angina within 6 months of starting study
• •* known CNS disease
• •* significant vascular disease
• •* symptomatic peripheral vascular disease
• •* evidence of bleeding diathesis or coagulopathy
• •* core biopsy or other minor surgical procedure (except placement of vascular access device) within 7 days of starting study
• •* history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study start
• •* proteinuria at screening