IRB Number:

07-003786

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study to find out the effects (good and bad) of the combination of gemcitabine and 17AAG has on a patient and their metastatic pancreatic cancer. Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) for use in metastatic pancreatic cancer. 17AAG is an investigational or experimental anti-cancer agent that has not yet been approved by the FDA for use in metastatic pancreatic cancer.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with metastatic pancreatic cancer
-No prior chemotherapy for metastatic (having spread outside of the pancreas) disease

*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 the patient has had some of them recently, they may not need to be repeated. This will be up to the study doctor.

- Complete Blood Count
- Liver function tests (bilirubin, AST, ALT, Alkaline Phosphatase)
- Kidney function tests (Creatinine)
- Measurement of patient's cancer (CT scan, ultrasound, or MRI)
- Research blood tests

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 they will need the following tests and procedures. They are part of regular cancer care.

- Complete Blood Counts
- Liver and Kidney function
- Imaging of patient's cancer (CT scans, ultrasound, or MRI)

Patients will need these tests and procedures that are either being tested in this study or being done to see how the study is affecting their body.

- Research blood tests will be collected prior to the patient's first treatment, 24 hours after they have completed the first treatment, at before the first treatment of each three-week cycle. Also, for the second cycle only, the patient will have blood collected at conclusion of the gemcitabine treatment and again one hour later.

Patients will be "randomized" into one of the study groups described below. Randomization means that the patient is put into a group by chance. A computer program will place the patient in one of the study groups. Neither the patient nor their doctor can choose the group the patient will be in. Patients will have a one in three chance of being placed in any group. The only difference in the three groups will be during the first week of the first cycle. After that, all treatments will be the same in all groups.

If patient is in Arm A
On day 1 and 8 of the first cycle, Gemcitabine will be given
intravenously. Beginning on day 9, 17AAG will be given intravenously. Beginning with the second cycle, the patient will receive gemcitabine on days 1 and 8, and 17AAG on days 2 and 9. This will be repeated every 21 days. 17AAG is an
investigational agent. This schedule is different from what is considered standard of care, which is to give gemcitabine at a slightly higher dose every three weeks out of four.

If patient is in Arm B
On day 1 and 8 of the first cycle, Gemcitabine will be given
intravenously. On days 2 and 9, 17AAG will be given intravenously. 17AAG is an investigational agent. This will be repeated every 21 days. This schedule is different from what is considered standard of care, which is to give gemcitabine at a slightly higher dose every three weeks out of four.

If patient is in Arm C
On day 1 and 9 of the first cycle, 17AAG will be given
intravenously. Beginning on day 8, gemcitabine will be given intravenously. This will be repeated every 21 days. Beginning with the second cycle, the patient will receive
gemcitabine on days 1 and 8, and 17AAG on days 2 and 9. 17AAG is an investigational agent. This schedule is different from what is considered standard of care, which is to give gemcitabine at a slightly higher dose every three weeks out of four.

All groups will have tumor measurements (as measured by CT scan, ultrasound, or MRI) every six weeks in order to determine clinical effect.

When finished taking gemcitabine and 17AAG, the patient will have their clinical data collected, but will have no specific follow-up requirements.

Patients will receive gemcitabine and 17AAG on consecutive days weekly for two weeks out of three (21 days) in this study. For the first two days of the treatment in the first cycle only, the patient will be randomized to receive either gemcitabine, 17AAG, or both. This 21 days period of time is called a cycle. Each cycle is numbered in order.

The drug used in this study is considered investigational, which means it has either not been approved by the 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.

MANDATORY TRANSLATIONAL RESEARCH:
Before treatment on cycle 1 day 1, cycle 1 day 2, cycle 1 day 3 (Arm B patients only), and before treatment on cycle 2 day 1, blood samples for research studies will be taken.
These samples are a requirement for participating in this study. These tests will require about 6-8 teaspoons of blood. The research blood samples will be taken before each
chemotherapy is put in the patient's vein. Blood samples for research studies will also be taken at the time a patient's cancer progresses. The research tests will look at how Gemcitabine and 17-AAG may affect the biology of metastatic pancreatic adenocarcinoma.

MANDATORY RESEARCH COMPONENT (FOR PRE-TREATMENT TISSUE, IF
AVAILABLE):
A part of the tissue taken during a biopsy or surgery obtained at the first diagnosis of the patient's cancer will also be used in this study. This is a requirement of the study. The research staff want to investigate whether specific characteristics of the tumor tissue relate to any benefits of 17AAG.

How long will the Study run?

Patients will be asked to take gemcitabine and 17AAG for six weeks at a time. If the chemotherapy appears to be working, and the patient can tolerate further treatment, the research staff will continue for two cycles at a time. After the patient is finished taking gemcitabine and 17AAG, the study doctor will collect clinical information from the patient's oncologist, but further visits are not necessary for the study. The researchers would like to keep track of the patient's medical condition for the rest of thier life. The research staff would like to do this by calling the patient on the telephone once a year to see how they are doing. Keeping in touch with the patient and checking on their condition every year helps us look at the long-term effects of the study.

Sponsor(s): Phase 2 Consortium, National Cancer Institute (NCI)

Study Activation/Registration Date: 03/20/2008

IRB Review and Approval Date: 02/28/2008

Study Type: Treatment

Projected Accrual: The plan is to have up to 72 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: Robert R. McWilliams, 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: 11/17/2008