Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignancies

Inclusion criteria

• Solid cancer for which curative measures have failed or for which there is no known superior treatment
• ECOG performance status 0-2
• Measurable or non-measurable disease
• Life expectancy of greater than 12 weeks and no anticipated need for other antineoplastic therapy in the next 4 weeks
• Age 18 years or older
• Patients must have adequate organ and marrow function as defined below:

• ALT and AST less than or equal to 2.5 x the ULN (< 5 x ULN for patients with liver involvement).
• hemoglobin greater than or equal to 9 g/dL
• absolute neutrophil count greater than or equal to 1,500/μL
• platelets greater than or equal to 100,000/μL (greater than or equal to 35,000/μL without transfusion for patients with CLL/SLL or follicular lymphoma)
• total bilirubin less than or equal to 1.5 x ULN
• creatinine less than or equal to 1.5 x ULN
• Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
• Ability to understand and the willingness to sign a written informed consent document
• Must not have any evidence of bleeding diathesis.

Exclusion criteria

• Patients who have had chemotherapy or immunotherapy within 3 weeks or radiotherapy within 14 days prior to entering the study
• Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy
• Patients with uncontrolled brain metastases.
• Concurrent illness or medication exclusions
• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib or rapamycin.