Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer
Urologic Neoplasm
About this trial
This is an interventional treatment trial for Urologic Neoplasm focused on measuring urothelial, urologic, neoplasm, advanced, metastatic
Eligibility Criteria
Inclusion Criteria: Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter) Measurable disease by RECIST Patients who received only one prior systemic non-taxane regimen for urothelial cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced disease. Signed IRB approved consent Must have tissue available for EGFR assessment and additional correlative studies ECOG PS 0-2 18 years of age or older Not of child bearing potential or negative pregnancy test within 7 days of treatment ANC greater than or equal to 1,500/ul Platelets greater than or equal to 100,00/ul Creatinine less than or equal to 2x institutional ULN or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST&ALT less than or equal to 5x ULN Exclusion Criteria: Received more than one prior regimen for advanced disease Prior radiation to more than 30% of marrow containing skeleton Prior therapy that specifically and directly targets the EGFR pathway Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2 Prior reaction to Cremophor EL Known acute hepatitis B or C or known HIV Active or uncontrolled infection Significant history of uncontrolled cardiac disease Any concurrent chemotherapy not indicated in this study; or Any other investigational agents
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm 2
Other
Other
Cetuximab alone
Cetuximab with Paclitaxel
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.