A Phase II Exploratory Study of Pre-Operative Treatment With Erlotinib (Tarceva) in Muscle Invasive or Recurrent Transitional Cell Carcinoma Requiring Cystectomy
The Study Drug:
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface
of many tumor cells that may control tumor growth and survival. This may stop tumors from
Study Drug Administration:
If you are found to be eligible to take part in this study, you will begin taking erlotinib
hydrochloride (a pill) by mouth once a day. You should take it at about the same time each
day, at least 1 hour before or 2 hours after a meal. You should swallow the pill with about
a cup (8 ounces) of water.
It is important that you take the drug every day, as prescribed. If necessary during the
study, the study doctor may decide to lower the dose.
Once a week during this study, you will have the following tests performed before you take
the study drug:
- Your vital signs will be measured.
- You will be asked about any side effects you may have experienced.
- Blood (about 1 teaspoon) will be drawn for routine tests.
Length of Study Participation:
You may continue receiving the study drug for 3-5 weeks (depending on when your surgery is
scheduled). After that, you will be offered surgery to remove the tumor. You will take
your last study drug dose within 24 hours before having surgery. You will sign a separate
consent form for the surgery, and the procedure and its risks will be described in more
detail at that time.
If the disease gets worse or intolerable side effects occur, you will be taken off study
If you stop taking the study drug early because of intolerable side effects, you will need
to return to the clinic every 2 weeks until surgery. At these visits, your side effects
will be monitored, for example with routine blood tests and/or scans, depending on what the
doctor decides is necessary.
After surgery, all study participants will return for routine follow-up visits with the
Every 6 months for the first year after surgery and once a year for the next 4 years after
that, the study staff will call you to see how you are doing.
This is an investigational study. Erlotinib hydrochloride is FDA approved and commercially
available for the treatment of non-small cell lung cancer and pancreatic cancer. Its use in
this study is investigational and not FDA approved. For this purpose, at this time it is
being used in research only.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate (ie: pT0 rate), defined as the absence of residual cancer in the resected specimen
Baseline response to response after 3 weeks of therapy
Arlene Siefker-Radtke, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|