Study of Axitinib and Temsirolimus in Solid Tumors

Inclusion criteria

/Exclusion Criteria:

• Patients must have histologically confirmed non-hematologic malignancy for which standard curative or palliative measures do not exist or are no longer effective
• Patients with hepatocellular carcinoma do not need histologic confirmation of malignancy if the following criteria were met at diagnosis:

• Liver lesions 1 - 2 cm with arterial enhancement and washout in venous phase of CT/MRI
• Liver lesions ≥ 2 cm with arterial enhancement and washout in venous phase of CT/MRI or serum alpha-feto protein ≥ 200 ng/mL
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Marrow and Organ function requirements:

• Absolute Neutrophil Count ≥ 1000/mm³
• Platelets ≥ 75,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastasis present or patient has diagnosis of hepatocellular carcinoma or cholangiocarcinoma)
• Creatinine ≤ 1.5 x ULN
• Urinalysis ≤ 1+ protein on dipstick or Urine creatinine:protein ratio < 1.0 If urine protein >1 1+ or urine creatinine:protein ratio > 1, then 24 hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment.
• Fasting serum cholesterol ≤ 350 mg/dL
• Triglycerides ≤1.5 x ULN
• Life expectancy ≥ 12 weeks
• At least 2 weeks since end of prior systemic treatment (4 weeks for bevacizumab containing regimens), radiotherapy, or surgical procedure with resolution of all treatment related toxicity
• No evidence of uncontrolled hypertension as evidenced by 2 readings of < 140/90 measured 1 hour apart. Preexisting hypertension controlled with medication is allowed
• No gastrointestinal disorders including active peptic ulcer disease (within 6 months); active bleeding unrelated to malignancy; or melena, hematemesis, or hematochezia in the past 3 months without endoscopically-proven resolution
• No cardiovascular history within 12 months including: myocardial infarction (MI), uncontrolled angina, coronary artery bypass graft (CABG), or symptomatic congestive heart failure (CHF)
• Women of child bearing potential must have negative pregnancy test
• Willingness and ability to comply with scheduled visits
• Able to ingest oral medications
• No concurrent use or anticipated need for potent cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 or cytochrome P450 1A2 (CYP1A2) inducers