Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine whether the investigational drug cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Cetuximab; Paclitaxel

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