Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer
Completed · Phase 2
Conditions studied: Urologic Neoplasm
In brief
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.
Key facts
- Study ID
- NCT00350025
- Run by
- Fox Chase Cancer Center
- People needed
- 41
- Starts
- 2006-08-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2017-03-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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