IRB Number:

592-04

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Gemcitabine is a U.S. Food and Drug Administration (FDA)-approved anti-cancer drug. 17AAG is an investigational drug. This study is being done to determine the effects (both good and bad), of gemcitabine in combination with 17AAG, when used in the treatment of patients with ovarian and primary peritoneal cancer. In particular, the effects of the gemcitabine/17AAG combination on cancer growth and extent will be evaluated using blood tests (such as CA125) and other testing (such as CT scans and chest x-rays) as suited for patients receiving both gemcitabine and 17AAG. Additionally, side effects of gemcitabine and 17AAG will be closely watched, with dosage changes made as needed to protect the health of treated patients. 17AAG can cause the damage of some kinds of proteins in cancer cells that keep the cancer from dying and promote the growth of the cancer. By destroying these proteins, 17AAG may shrink the cancer or slow the growth of the cancer. In experiments done by Dr. Haluska and his collegues, the effects of 17AAG on cancer cell death was greatly increased when gemcitabine was given prior. In patients that have previously received gemcitabine, we will learn whether 17AAG can reverse tumor resistance to gemcitabine and shrink tumors in patients with ovarian and primary peritoneal cancers. In patients who have had no prior exposure to gemcitabine, we will learn whether the combination of gemcitabine and 17AAG has the ability to shrink tumors in patients with ovarian and primary peritoneal cancers.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with relapsed (recurring) ovarian or primary peritoneal cancer.
-Patients with either measurable or evaluable disease will be permitted to enroll in the trial. In particular, patients with rising CA125, even in the absence of other indicators of disease, may be enrolled if CA125 is 2 x the UNL (Upper Normal Limit).
-Prior treatment with gemcitabine is allowed.

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

What is Involved With this Study?

What will happen in the research study:
Cycle 1: Patients will be given 17AAG into a vein in their arm over two hours on the first day of treatment. Six days later the patient will receive gemcitabine into a vein in their arm over 30 minutes. A day later the patient will receive a second treatment of 17AAG. This will be followed by a 2-week rest period when no gemcitabine/17AAG treatment will be given.

Cycle 2: The next cycle (21 days after the 1st treatment) will vary slightly. Gemcitabine will be given on day 1, then 17AAG will be given on day 2. This will be repeated a week later and then will be followed by a 1-week rest period when no gemcitabine/17AAG treatment will be given.

After Cycle 2: This schedule will be repeated as long as the patient has no serious side effects and the cancer is not getting worse.

Before the patient's first 17AAG treatment and between 22 and 26 hours after that treatment, samples of blood and a biopsy of tumor tissue will be taken.

Patients will have blood tests at least once weekly during the study. 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 before starting treatment and following treatment to measure the cancer. These blood tests and measurement exams are part of the routine care given to cancer patients.

In addition to this tests will be done to ensure the patient does not have any medical conditions that would make giving 17-AAG unsafe. Patients will have several EKGs
(electrocardiograms), which are a painless test involving an electrical measurement of their heart. Patients will also have breathing tests (Pulmonary Function Test (PFT); DLCO; pulse oximetry), which will measure the status of their breathing ability to make sure it is sufficient enough to go on study. These tests are not part of routine care for cancer patients. Thus, the patient or their insurance company will not be charged for these costs.

A tumor biopsy will be done if the patient has accessible tumor tissue. A biopsy will be done before the patient's first treatment and 22-26 hours after the start of treatment on day 1. These research blood and tissue sample collections are a requirement of the study. These biopsies will help Dr. Haluska and his colleagues understand how the treatment if affecting the tumor cells and determine what changes are seen when the tumors shrink. As these biopsies are research related, the patient or their insurance company will not be charged for these costs.

How long will the Study run?

Patients will be in the study for at least three weeks. After three weeks of treatment with gemcitabine and 17AAG, patients will be checked for side effects and anti-cancer effects to determine whether the drug should be continued. If side effects are modest, and the patient appears to be benefiting from gemcitabine and 17AAG in terms of their cancer, then the gemcitabine/17AAG combination can be continued, until troublesome side effects or tumor growth occurs.

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

Study Activation/Registration Date: 07/27/2004

IRB Review and Approval Date: 06/04/2004

Study Type: Treatment

Projected Accrual: The plan is to have up to 78 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, 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
• Scottsdale and Phoenix, AZ

Last updated: 06/16/2008