Trial Information

Summary: Randomized phase III study for stage II colon cancer at high risk for recurrence Comparing 5-FU, leucovorin and Oxalplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab to determine prospectively the prognostic value of molecular markers

A marker evaluation of your tumor will be done if it demonstrates you to be at low-risk for tumor recurrence, then you will have regular follow-up to monitor your health, but will not receive any further treatment for the cancer including chemotherapy.

If the tumor marker shows high-risk for tumor recurrence the you will be randomized into one of two study groups.

Arm A standard regimen of chemotherapy 5-FU/leucovorin/oxaliplatingiven on days 1 and 2 every 2 weeks for a total of 12 cycles
Arm B standard two-day regimen of chemotherapy 5-FU/leucovorin/oxaliplatin given on days 1 and 2, every two weeks for a total of 12 cycles

You will also receive bevacizumab on day 1 every two weeks

Patient Inclusion Criteria:

  • Stage II colon adenocarcinoma
  • Patients must have greater and/or equal 8 lymph nodes evaluated
  • Patients must not have had any systemic or radiation therapy
  • Patients must be 18 or older
  • Patients must have good performance status

Patient Exclusion Criteria:

  • Surgery past 60 days from day of registration
  • Pregnant and/or nursing
  • Patients with non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude them from receiving the drugs
  • Patients with psychiatric or addictive disorders

Primary Outcomes:

To demonstrate disease free survival
To prospectively determine the impact of tumor biological characteristics on the survival of patients with stage II colon cancer

Contact:

Janeen V. Bazan, Oncology Research Nurse and Program Coordinator
Sherman Health Systems
934 Center Street
Elgin, IL 60120
Telephone: 847-429-2907
Fax: 847-429-3071
Email:

Profile Page: Sherman Health Systems, Elgin, IL

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: June 1, 2008 at 5:45:50 AM


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