Phase II Study of BAY 43-9006 (NSC #724772) as Single Agent in Unresectable or Metastatic Gallbladder Carcinoma and Cholangiocarcinoma

Cytologically or pathologically confirmed diagnosis of cholangiocarcinoma or gallbladder carcinoma. Locally advanced or distant metastatic dz not surgically curable. Measurable dz. Measurable dz assessed within 28 days prior to reg; non-measurable dz assessed within 42 days prior to reg. Submit paraffin-embedded specimens. Seek additional consent to submit blood. Must be at least 14 days beyond any major surgery and recovered from effects. No prior therapy for unresectable or metastatic dz. May have received prior chemo, hormonal therapy, immunotherapy, RT (to less than 25% of bone marrow only) or chemoradiotherapy as neoadjuvant or adjuvant tx. This must have been completed at least 12 months prior to documented recurrence or metastatic dz. Must have recovered from RT toxicities. Prior RT to metastatic sites allowed as long as pt has measurable lesion(s) that were not treated with RT. At least 28 days must have elapsed since completion of RT and pt must have recovered from effects. No prior BAY 43-9006 or any inhibitor of VEGFR or the MAPK pathway. Zubrod PS 0-1. Within 14 days prior to reg: total serum bilirubin less than or equal to 3 x IULN; SGOT or SGPT less than or equal to 2.5 x IULN (if liver mets present, SGOT or SGPT less than or equal to 5 x IULN); serum creatinine less than or equal to 1.5 x IULN OR measured or estimated creatinine clearance greater than or equal to 60 mL/min; leukocytes greater than or equal to 3,000/mcL; ANC greater than or equal to 1,000/mcL; platelets greater than or equal to 100,000/mcL; PT, INR and PTT less than or equal to IULN. Must not be taking the cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin, or St. Johns Wort. Must not be on therapeutic anticoagulation. No evidence of bleeding diathesis. No clinically significant cardiac disease not well-controlled by meds or MI within 12 months prior to reg. No uncontrolled hypertension. No known brain mets. Must be able to swallow and/or receive enteral meds via gastrostomy feeding tube. No malabsorption syndrome. No intractable nausea or vomiting. No plans to receive concurrent treatment except RT for palliation to metastatic sites. No pregnant or nursing women. Pts of reproductive potential must agree to use adequate contraception. If HIV-positive, must have CD4 count > 500 and must have no active opportunistic infection. Must not be receiving combination anti-retroviral therapy. No prior malignancy except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the pt has been dz free for 5 years.