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Investigator(s):
Shivaani Kummar, M.D., F.A.C.P. Principal Investigator Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov	Deborah Allen, R.N., O.C.N. Research Nurse Phone: 301-402-5640 Fax: 301-480-7281 allendeb@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed alveolar soft part sarcoma (ASPS) that is not curable by surgery
• Metastatic disease
• Not curable by surgery; surgically resectable tumors with metastasis will be considered on a case-by-case basis
• Evidence of objective disease progression per RECIST 1 on scans at least 6 weeks apart within the 3-month period immediately preceding enrollment
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
• ≥ 16 years of age
• ECOG ≤ 2
• Absolute neutrophil count ≥ 1,500/microL
• Platelets ≥ 100,000/microL
• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)
• No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements

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Study Outline:

• Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
• In Part I, patients are randomized to receive either cediranib or sunitinib by mouth once a day in 28-day treatment cycles
• Cycles continue until that drug is no longer working to control the cancer or there are unacceptable side effects
• 2 week break from study treatment before starting Part II*
• Part II: The study drug (either cediranib or sunitinib) that was not given in Part I, by mouth once a day in 28-day treatment cycles
• Cycles continue until that drug is no longer working to control the cancer or there are unacceptable side effects
• Participants will have blood samples, physical examinations, and tumor imaging studies throughout the clinical trial

* If too many patients in a treatment arm have serious side effects or not enough patients have disease that responds, that treatment arm may be closed to new patients. Participation in the study would end after completion of Part I.

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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: 3/21/13
Updated: 9/25/12