IRB Number:

1930-04

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to learn:
- The highest safe dose of the cancer drug called CP-751,871 that can be given every three weeks with paclitaxel and carboplatin to patients with cancer without causing bad side effects;
- About the side effects (good or bad) of CP-751,871, paclitaxel and carboplatin when given together;
- How the body handles or processes CP-751,871 when given with paclitaxel and carboplatin;
- If the patient's body generates antibodies (substances produced by the immune system to help fight infectious or foreign materials) against CP-751,871; and
- If CP-751,871 helps paclitaxel and carboplatin to fight the patient's cancer.

CP-751,871 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) for standard clinical use. This drug will be available to patients only during this study. Paclitaxel has been approved by the FDA for the treatment of lung cancer, but has not been approved in the combination used in this study, and its use is considered investigational. Carboplatin has been approved by the FDA for the treatment of ovarian cancer, but has not been approved in the combination used in this study, and its use is also considered investigational.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with stage IIIB or stage 4 non-small cell lung cancer (NSCLC)
-No prior chemotherapy treatment received

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

What is Involved With this Study?

Before starting any study treatment, patients will have certain tests and procedures to determine whether they can take part in this study.
-Medical history/ physical exam
-CT scan
-Electrocardiogram (a test which measures the electrical activity of the heart)
-Echocardiogram (an ultrasound of the heart), which will allow their doctor to see how well their heart is working
-Blood tests
-For women able to become pregnant, a pregnancy test

Patients will receive three different drugs during their treatment. Treatment on this three-part study will follow a three-week schedule, and each three-week period is known as a "cycle." In the first part of the study we are trying to find out the highest dose of the study drugs that can be safely given together. To find the highest doses of CP-751,871, paclitaxel, and carboplatin that can be given together, the first group of three to six patients will receive lower doses of CP-751,871. The doses of paclitaxel and carboplatin are the standard doses and will stay the same for up to 6 cycles of the study for all patients who complete six cycles. If the first three to six patients do not have severe side effects, the next group of 3-6 patients will get higher doses of the CP-751,871. The doses of CP-751,871 will be increased until at least some patients have severe side effects. The dose that the patient gets will not increase during this study, but if they have bad side effects, their dose of CP-751,871, paclitaxel or carboplatin may be lowered at future visits. All patients will be watched carefully for any serious side effects. These side effects cannot be completely known ahead of time. This study may involve significant risks for this reason.

Patients will be given CP-751,871, paclitaxel and carboplatin in their vein on the first day of every three week cycle, as explained above. The three-week cycle of treatment with CP-751,871, paclitaxel and carboplatin will be repeated six times as long as the patient does not have serious side effects and their cancer does not get worse. After that a patient may receive additional three-week cycles of CP-751,871 for up to one year if their doctor determines that this may be beneficial to the patient and they wish to remain in the study.

Patients will have their treatment as an outpatient. During the treatment, patients will have their blood pressure, temperature and pulse checked during the drug infusions. Patients will need to remain in the treatment room for one to two hours after the infusions are completed.

Patients will have blood tests after every cycle (every three weeks). These tests are needed to measure their blood cell counts and/or blood chemistries. X-rays, CT scans, and magnetic resonance imaging (MRI) tests may also be done to measure the cancer after every other cycle or sooner if their doctor considers that this is necessary. These blood tests and measurement exams are part of the routine care given to cancer patients.

If the patient and their research doctor decide that they will have more than one cycle of this treatment, the patient will have their intravenous study drug treatments as an outpatient.

How long will the Study run?

Patients will be in the study until the side effects are too bad, or they decide to stop, or if their cancer gets worse. For up to one year after the patient's last treatment on this study, follow-up information will be collected from the patient and then they will be off the study.

Sponsor(s): Pfizer

Study Activation/Registration Date: 03/23/2005

IRB Review and Approval Date: 09/30/2004

Study Type: Treatment

Projected Accrual: The plan is to have up to 24 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: Paul Haluska, Jr., MD, PhD

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: 06/18/2008