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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	Michelle Eugeni, R.N., B.S.N., O.C.N. Phone: 301-594-4325 Fax: 301-480-7281 meugeni@mail.nih.gov

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Key Eligibility Criteria:

• Histologically or cytologically confirmed soft tissue sarcoma that is metastatic or unresectable and for which standard treatment that prolongs survival does not exist or is no longer effective
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as > 20mm with conventional techniques or as > 10mm with spiral CT, MRI, or calipers by clinical exam
• ECOG ≤ 1 (Karnofsky > 70 percent)
• Normal organ and marrow function as evidenced by: absolute neutrophil count ≥ 1,500/mcL; platelets ≥ 100,000/mcL; total bilirubin ≤ 1.5 x ULN (upper limit of normal); hemoglobin ≥ 9g/dL; PT/PTT/INR ≤ 1.3 x ULN
• ≥ 18 years of age
• Able to swallow whole tablets or capsules
• Blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility (Initiation or adjustment of BP medication is permitted)
• Not pregnant or nursing
• Agrees to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of the study drug administration
• 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 and imaging studies to determine eligibility for the study
• Participants will take cabozantinib tablets by mouth daily for 28-day cycles of treatment
• Cycles repeat every 28 days for as long as there is no progressive disease or unacceptable toxicity
• Participants will be monitored with blood samples and physical examinations
• Tumor imaging studies will occur after every two cycles of treatment

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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.

Reviewed: 
Updated: 12/27/12