Urologic Neoplasm Clinical Trial
Official title:
Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment