IRB Number:

06-005593

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study because they have been diagnosed with non-small cell lung cancer (NSCLC).

The purpose of this research study is to:
- Compare the effects, good and/or bad, of using BAY 43-9006 in combination with pemetrexed versus pemetrexed alone, on the patient's non-small cell lung cancer (NSCLC)
- Find out if there are individual differences and/or tumor characteristics that will affect response to treatment

BAY 43-9006 is an U.S. Food and Drug Administration (FDA)-approved drug for the treatment of kidney cancer. Pemetrexed is a standard chemotherapy drug that is used in patients with this type of lung cancer that did not respond to or that progressed after a first course of treatment.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC)
- Previously treated with at least one chemotherapy regimen

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

What is Involved With this Study?

If agreeing to be in the study, patients will be asked to participate in the following:

Before beginning the study-

Patients will need to have the following exams, tests or procedures to find out if they can be in the study. These exams, tests or procedures are part of regular cancer care and may be done even if the patient does not join the study. If they have had some of them recently, they may not need to be repeated. This will be up to the study doctor.

- Medical history
- Complete physical exam, including blood pressure measurement
- Blood tests
- X-rays or CT scans for tumor measurement
- Pregnancy test for women who are able to become pregnant

During the study-

If the exams, tests and procedures show that the patient can be in the study, and they choose to take part, then the patient will need the following tests and procedures. They are part of regular cancer care.
- Medical history and physical exam prior to each cycle of treatment (once each cycle)
- Tumor will be measured every other cycle (one cycle is 21 days). However, if their tumor looks like it is responding to treatment, another x-ray/scan will be taken before the next cycle of treatment to check to see if the tumor has continued to respond to the treatment. The study doctor may also want to do an X-ray/scan if the patient's tumor looks like it is getting worse.
- Blood tests
- A research blood draw will be taken to help see how the treatment the patient gets will affect their body

Patients will be "randomized" into one of the study groups described below: Randomization means that the patient is put into a group by chance (as in the flip of a coin). A computer program will place the patient in one of the study groups. Neither the patient nor their doctor can choose the group they will be in. There is a 50 percent chance that the patient will be assigned to the study group that receives pemetrexed in combination with BAY 43-9006 (group A) and a 50% chance they will be assigned to the standard treatment of pemetrexed alone (group B).


Past studies of patients taking pemetrexed have shown that a high level of a naturally-occurring compound (a certain amino acid in a patient's blood called homocysteine) may give the patient a higher risk of getting serious side effects. To try to lower the risk of bad side effects, the patient will have to take folic acid pills (or an equivalent vitamin supplement) daily, starting about seven days before getting the first dose of treatment. They will then need to take it daily until three weeks after they have stopped getting pemetrexed. Also, the patient will be given a shot of vitamin B12 into a muscle in their arm or hip on the same day they start the folic acid (or seven days before getting treatment with pemetrexed if they are already taking an equivalent vitamin supplement) and then once every nine weeks until three weeks after they have stopped getting pemetrexed.

Before getting treatment, the patient will get a cortisone-type medication (dexamethasone) by mouth the day before, the day of, and the day after all doses of pemetrexed to help stop the development of a rash.

Before getting treatment, the patient will get medications that help fight the feeling of being sick to their stomach and throwing up.

Because high blood pressure is a side effect of taking BAY 43-9006, and because the research staff want to compare the difference in blood pressure changes that happen in patients in group A with group B, it will be important that the patient's blood pressure be taken and recorded at least weekly during the first cycle of treatment. The blood pressure can be done by either a health care professional (e.g. physician, physician assistant, nurse, etc), at home if the patient has a blood pressure monitor, at a senior center, or at a pharmacy.

If a patient is in group A, pemetrexed will be given through a needle in their vein on the first day of every cycle over 10 minutes. They will also take BAY 43-9006, two tablets by mouth twice a day every day. The patient will take the pills home. A cycle of treatment covers a 21-day period of time. The cycle will be repeated until their disease gets worse or the side effects are too bad.

A diary that keeps track of the number of pills the patient takes will need to be filled out every day during the time they are taking BAY 43-9006 and returned with each visit to the clinic.

If a patient is in group B, pemetrexed will be given through their vein on the first day of every cycle. A cycle of treatment covers a 21-day period of time. The cycle will be repeated until their disease gets worse or the side effects are too bad.

This study also has required laboratory tests that will be done to study small samples of blood and using tissue from the patient's original lung biopsy. Blood samples will be collected day 1, cycle 1, before the start of treatment and 24 hours after treatment; before the start of treatment on day 1, cycle 2; and before the start of treatment on day 1, cycles 3 and 5. Patients will have already had a biopsy (or surgery) to see if they had cancer, which is part of their regular medical care. No additional biopsies will be done to get this tissue. These tests are for research purposes only and you will not have to pay for them.


The drug (BAY 43-9006) used in this study is considered investigational, which means it has either not been approved by the U.S. Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug in this research study.

How long will the Study run?

Patients will be asked to take pemetrexed with or without BAY 43-9006 until their tumor gets worse. After that, the research staff would like to keep track of the patient's medical condition for about five years. Keeping in touch with the patient and checking on their condition every year helps the researchers look at the long-term effects of the study.

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

Study Activation/Registration Date: 10/11/2007

IRB Review and Approval Date: 08/02/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 104 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
• Scottsdale and Phoenix, AZ

Last updated: 06/10/2008