IRB Number:

2139-04

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to find the highest dose of the investigational drug PS-341 that can be given in combination with carboplatin, paclitaxel, and radiation therapy without causing bad side effects.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with Non-Small Cell Lung Cancer which has not spread to other parts of the body
-No prior radiation or chemotherapy received

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Patients will have a full medical history taken and physical exam along with a chest X-ray, CT scan, and other tests that the researcher might feel are needed to fully learn about their disease and see if they can be on this study.

Patients will be given PS-341 into a vein in their arm over a very short period of time on days 1, 4, 8, 11, 22, 25, 29, 32; paclitaxel will be given into a vein in their arm over three hours on days 2 and 23; and following the paclitaxel infusion, carboplatin will be given into a vein in their arm over 30 minutes on days 2 and 23.

Radiation therapy will begin on day 1 and continue Monday-Friday for six weeks. Four weeks after the radiation therapy is done, patients will have routine blood tests and scans to see how their disease has responded to the treatment. If their disease has not gotten worse four weeks after radiation therapy evaluation, they will also have routine blood tests, history/exam and CT chest scans three months after radiation therapy is done, then every three months for one year, and then every six months for up to five years from the time the patient went on study.

How long will the Study run?

Patients will be followed for up to five years from the time they started treatment on this study so that the researchers can watch their health status.

Sponsor(s): North Central Cancer Treatment Group (NCCTG)

Study Activation/Registration Date: 11/18/2004

IRB Review and Approval Date: 10/22/2005

Study Type: Treatment

Projected Accrual: The plan is to have up to 66 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Julian Molina, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL

Last updated: 07/03/2008