Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer
18 Years
N/A
Both
Urologic Neoplasm
Trial Information
Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer
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 factor receptor (EGFR). EGFR sits on the outside of tumor cells and
controls tumor cell growth. This agent has been looked at alone and with other chemotherapy
drugs including paclitaxel. It has been found to be safe and can shrink other types of
cancer.
This research study is also being done to find out if cetuximab, alone or with paclitaxel
shrinks urothelial tumors. If it extends the time the tumors shrink. If it helps people
live longer.
The purpose of this research study is to find out what effects (good and bad) these
treatments have on you and your cancer. We do not know if you will benefit from this
research study. It is possible that your condition will get better, but it is also possible
that there will be no effect on your condition or that your condition will get worse. We
can use what we learn from this research study to help other people with the same disease.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.
Safety Issue:
No
Principal Investigator
Yu-Ning Wong, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
FER-GU-004
NCT ID:
NCT00350025
Start Date:
August 2006
Completion Date:
September 2012
Related Keywords:
- Urologic Neoplasm
- urothelial
- urologic
- neoplasm
- advanced
- metastatic
- Neoplasms
- Urologic Neoplasms
Name | Location |
|---|---|
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
