On Trial

Winter 2010

In this issue of “On Trial” we are providing information on one clinical trial and one survey research project on bladder cancer survivorship.

Phase 2 Study – Neoadjuvant Chemotherapy with Dose-Dense MVAC in Muscle-Invasive Urothelial/Bladder Cancer.

Dana-Farber Cancer Institute is enrolling patients into a phase 2 neoadjuvant study of dose-intensified chemotherapy with MVAC (dose-dense MVAC) and growth factor support in patients with muscle-invasive bladder cancer. Patients with clinical T2-T4a and N0-N1 are eligible provided they have good performance status and they are eligible for cisplatin-based chemotherapy. The dose-dense regimen will be given for 4 cycles followed by radical cystectomy and lymph node dissection. This regimen has been tested in the advanced/metastatic setting and was found to be better tolerated than the classic MVAC (less mucositis, neutropenia and infection) with higher rate of complete responders.

Our goal is to reach higher complete response in the tumor specimen than with classic chemotherapies such as MVAC or gemcitabine+Cisplatin, with the goal of achieving higher cure rates. The study will be collecting patients’ serum and tumor specimens’ in order to identify biomarkers of response and improved outcome with this regimen.

The study is set to open also at University of Pittsburgh, Pittsburgh, PA and Lahey Clinic, Burlington, MA

Overall PI [Primary Investigator] is Toni K. Choueiri, MD, genitourinary oncologist at Dana-Farber Cancer Institute and Harvard Medical School, email: Toni_Choueiri@dfci.harvard.edu

The purpose of this research study is to test the effectiveness of neoadjuvant chemotherapy (dose-dense MVAC) in combination with pegfilgrastim followed by radical surgery in patients with muscle-invasive urothelial carcinoma.  For full details, see the study listing at ClinicalTrials.gov.

Researchers Recruiting Men and Women Diagnosed with Bladder Cancer within the Last Four Years for a Telephone Survey

Have you been diagnosed with bladder cancer?

Would you help us with a survey about your experiences with this type of cancer?

Baylor College of Medicine and the Michael E. DeBakey VA Medical Center are conducting a research program trying to understand how cancer affects the lives of men and women. The goal is to create a new patient education and counseling program for bladder cancer patients, so we need to understand your concerns.

Participation in the research project will not cost you anything and does not affect your healthcare.

The Project

People who take part in the project can expect

• A short phone call to make sure you are eligible to be in the study
• A phone-based survey that will last 45 to 60 minutes.
• The survey will include questions about when you were diagnosed, how you feel about having cancer, and how having cancer has affected your life.
• Participants will be compensated $25 upon completion.

Eligibility

To be eligible for the study, you must be

• Diagnosed with bladder cancer within the last 4 years
• Able to speak English
• Able to receive project information through the mail and complete a survey by phone.

All information is CONFIDENTIAL.

This study is funded by the Scott Department of Urology at Baylor College of Medicine and is not associated with any business or commercial organization.

For more information, contact the Bladder Cancer Patient Education Program at 1-877-794-7852 or CancerOutcomes@bcm.edu.