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Pancreas Cancer

Pazopanib study at JHH was posted 11/30/2009 01:02 pm by Anonymous
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A Phase 1 and Pharmacokinetic Single Agent Study of Pazopanib in Patients with Advanced Malignancies and Varying Degrees of Liver Dysfunction. Number: J0849 Phase: Phase I Physician: Rudek-Renaut, Michelle Purpose: To establish the maximum tolerated dose and dose-limiting toxicities of Pazopanib in groups of patients with varying degrees of Liver Dysfunction. To document the non dose-limiting toxicities of Pazopanib in patients with Liver Dysfunction. To characterize the pharmacokinetic and pharmacodynamic profiles of Pazopanib. To determine any anti-tumor activity associated with Pazopanib treatment of patients enrolled on this study.

Eligibility: -Patients must have a confirmed diagnosis of a solid tumor or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. -Must be at least 18 years of age. -Must be able to complete their activities of daily living by themselves or with minimal assistance. -Must have adequate organ function (other than liver). -Patients that have involvement of their brain or nervous system from their cancer, or have a glioma must be on a stable dose of steroids and have had no seizures within one month of enrollment. -Patients that have had a history of blood clots must be on a stable dose of heparin therapy and have no symptoms. Pts on Coumadin are not eligible. -If a biliary shunt is required, the shunt must have been placed at least 10 days prior to starting treatment, and liver function stable. -Patients that are taking medications for seizures because of brain metastasis must not be on any meds that are on the prohibited medication list. The medication should be changed at least 7 days prior to the start of treatment. The research staff will be asking for a list of all of your medications. -All patients of child bearing potential must agree to use adequate forms of contraception prior to starting treatment and during the treatment. -There must have been at least three weeks since receiving their last dose of chemotherapy and four weeks since last radiation. -No major surgery within 28 days prior to treatment. -No prior treatment with Pazopanib, and no current treatment with any investigational drug. -No history of HIV. -Must be able to swallow the tablets whole (these tablets cannot be crushed or broken).

Treatment: Patients will be screened for eligibility with lab tests and CT scans as indicated. Patients entering the study will be stratified into four groups (normal, mild, moderate and severe) according to their level of liver dysfunction. Study medication is an oral agent. Each cycle is 21 days. Re-evaluation will take place as indicated for diagnosis.

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