Hematology & Blood Disorders

Category: Cancer (Oncology), HIC#13711
Title:
A Randomized Phase III Study Comparing 5-FU, Leucovorin, and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers.
Contact:Meredith Gross
Phone:(434)924-2745
E-mail:mpg8b@virginia.edu

UVa Health System, Department of Medicine, Hematology/Oncology seeks: Men and women ages 18 years and older with Stage II colon cancer who have previously had surgery for research study.

The purpose of the study is to determine whether a colon tumor can be used to predict recurrence of tumors in patients with Stage II colon cancer. The study compares the effects of a combination of chemotherapy drugs when given with and without a new investigational drug bevacizumab, on patients with stage II colon cancer at high-risk for recurrence. This study involves taking an experimental medication, a physical exam, blood tests, urine test and a pregnancy test for females who are able to become pregnant. This is a two day treatment, given every two weeks. The treatment period should last about 6 months, with annual physical exams and blood tests for up to 10 years.

Study-related experimental medications, tumor tissue testing and the evaluation of the tumor biological markers will be provided free of charge. However, if during the trial the experimental drugs are approved for stage II colon cancer, you and/or your health plan may have to pay for the drugs to complete the study.

Participant's insurance company will be billed for the cost of supplies, the personnel who give the drugs, and procedures.

No compensation is provided for this study.

Contact Information:
For more information please contact:
" Meredith Gross
" Tel: (434) 924-0436 Email: mpg8b@virginia.edu
" Insert IRB-HSR # 13711

Principal Investigator: Geoffrey Weiss, MD

Primary Investigator: Harris Thomas, J
Department: Internal Medicine
Division: Hematology/Oncology
Accepts adult enrollment :YES
Accepts minor enrollment :NO