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Investigator(s):
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Sonja Crandon, R.N. Research Nurse Phone: 301-594-4325 Fax: 301-480-7281 crandons@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed solid tumor or lymphoma that is metastatic or unresectable
• Meets one of the following criteria for hepatic function:
• Total bilirubin (> 35% direct) normal AND ALT normal
• Total bilirubin (> 35% direct) ≤ 1.5 x upper limit of normal (ULN) AND any ALT
• Total bilirubin (> 35% direct) ≤ 3 x ULN AND any ALT
• Total bilirubin (> 35% direct) > 3 x ULN AND any ALT
• No unstable or untreated (non-irradiated) brain metastases
• Recovered from all prior therapy
• No concurrent CYP450 substrates or potent CYP3A4 inducers or inhibitors
• No concurrent full-dose warfarin anticoagulation therapy
• No prior pazopanib hydrochloride
• Karnofsky performance status 60–100%
• ANC ≥ 1,500/mm³; platelet count ≥ 100,000/mm³; creatinine normal OR creatinine clearance ≥ 60 mL/min; urine protein ≤ 1+ by dipstick urinalysis OR urine protein < 1 g by 24-hour urine collection
• Not pregnant or nursing; fertile patients must use non-hormonal double barrier contraception prior to, during, and for 3 months after completion of study treatment
• Biliary obstruction for which a shunt has been placed is allowed provided the shunt has been in place for ≥ 10 days prior to the first dose of pazopanib hydrochloride and liver function has stabilized
• No medical condition that would preclude study participation
• No history of allergic reactions attributed to microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, titanium dioxide (E171), hypromellose (E464), polyethylene glycol 400 (also known as macrogol 400), or polysorbate 80 (E433)
• Ability to swallow whole pills

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Treatment Plan:

This is a multicenter study. Patients are stratified according to hepatic function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).

• Patients receive oral pazopanib hydrochloride once daily on Days 1–21
• Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
• Blood samples are collected at baseline and weekly during study
• Patients will maintain a blood pressure log
• After completion of study therapy, patients are followed for 1 month

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 10/28/08
Updated: 1/28/09