Neoadjuvant Erlotinib (Tarceva) in Transitional Cell Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Exploratory Study of Pre-Operative Treatment With Erlotinib (Tarceva) in Muscle Invasive or Recurrent Transitional Cell Carcinoma Requiring Cystectomy|
- Response Rate (ie: pT0 rate), defined as the absence of residual cancer in the resected specimen [ Time Frame: Baseline response to response after 3 weeks of therapy ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Erlotinib Hydrochloride
Erlotinib Hydrochloride 150 mg (pill) by mouth daily for 3 to 5 weeks prior to surgery.
Drug: Erlotinib Hydrochloride
150 mg (pill) by mouth daily for 3 to 5 weeks prior to surgery
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 growing.
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 early.
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 surgeon.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749892
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Arlene Siefker-Radtke, MD||M.D. Anderson Cancer Center|