Status:
COMPLETED
Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Urologic Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
This research study is being done to find out if cetuximab, alone or with paclitaxel will slow the growth of urothelial cancers. Cetuximab is an antibody that blocks a protein called epidermal growth ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00350025
Start Date
August 1 2006
End Date
September 1 2012
Last Update
March 31 2017
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111