S0718 Pazopanib and Temsirolimus in Treating Patients With Advanced Solid Tumors

DISEASE CHARACTERISTICS:

• Cytologically or pathologically verified cancer that is of advanced stage and for which there is no effective therapy
• No lymphoma
• Measurable or nonmeasurable disease
• Previously irradiated (whole brain or gamma knife) brain metastases allowed provided there is no requirement for corticosteroids or anticonvulsants

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL (without transfusions)
• AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver metastases present)
• Bilirubin normal
• Serum creatinine ≤ 1.5 times ULN OR measured creatinine clearance OR calculated creatinine clearance ≥ 60 mL/min
• QTC interval < 480 msec on baseline ECG OR average QTC < 480 msec on baseline plus 2 additional screening ECG's
• Fasting cholesterol < 350 mg/dL
• Fasting triglycerides < 400 mg/dL
• No uncontrolled hypertension, arterial thrombotic event, or bleeding on therapeutic anticoagulation with warfarin or heparin (including low molecular weight heparin) within the past 6 months
• Able to swallow enteral medications
• No feeding tubes
• No intractable nausea or vomiting
• No gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease (e.g., Crohn, ulcerative colitis)
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin analogs (e.g., sirolimus and everolimus)
• No known HIV positivity
• No uncontrolled intercurrent illness including, but not limited to, the following:
• Ongoing or serious active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Serious cardiac arrhythmia
• History of myocardial infarction
• Cerebrovascular accident within 3 months of study entry
• Uncontrolled diarrhea
• Psychiatric illness or social situation that would limit compliance with study requirements
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception, including barrier methods
• Willing to undergo pharmacokinetic (PK) sampling and blood submission for PK and translational medicine studies

PRIOR CONCURRENT THERAPY:

• Recovered from all prior therapy
• No prior pazopanib hydrochloride or temsirolimus
• More than 28 days since prior major surgery, chemotherapy, biologic therapy, or immunotherapy
• More than 28 days since prior investigational agents
• At least 14 days since prior radiotherapy
• No concurrent rapamycin (sirolimus)
• No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), CYP3A4 inducers (e.g., rifampin or St. John's wort), or CYP3A4 inhibiting agents or substrates (e.g., ketoconazole, diltiazem, or verapamil)
• No concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of this cancer while on this protocol
• No live vaccines
• Luteinizing-hormone releasing-hormone agonists allowed
• Concurrent prophylactic warfarin (≤ 1 mg/day) allowed
• Concurrent bisphosphonate or erythropoietin or its analogue allowed, if deemed appropriate by the treating physician