IRB Number:

07-003645

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Patients are being asked to take part in this research study because they have cancer of the cervix. This study is being done to determine if combining Tirapazamine (TPZ) with Cisplatin during radiation therapy increases the amount of time until a patient's cancer returns compared with Cisplatin and radiation therapy alone.

The Tirapazamine (TPZ) used in this study is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA) for either 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.

Who is Eligible to Participate in the Study?

*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 do 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 patients do not join the study. If patients have had some of them recently, they may not need to be repeated. This will be up to the study doctor.

- A cervical biopsy will have already been performed. A second tumor biopsy may sometimes be needed to confirm eligibility for this study. Leftover samples of this tissue will also be allowed for research testing. These tests
will be done in order to understand how the patient's cancer responds to treatment. It is hoped that this will help investigators better understand this type of cancer.
- A physical examination to include pelvic examination
- Blood tests including markers of anemia, electrolytes, kidney and liver function
- An assessment of the patient's tumor by CT (computerized tomography) scan, PET CT (positron emission tomography) scan, or MRI (magnetic resonance imaging) of the abdomen and pelvis
- An audiogram (hearing test) if the patient has hearing loss
- A chest X-ray
- A pregnancy test (if the patient is a women able to become pregnant) to be done within seven days before registration
- Research blood test. A sample of the patient's blood (approximately 1 tablespoon) will also be allowed for research testing. These tests will be done in order to understand how the patient's cancer responds to treatment.

If the exams, tests and procedures show that the patient can be in the study, and the patient chooses to take part, the patient will need the following tests and procedure during the study. They are being done more often than standard clinical care because the patient is in this study and to see how the study is affecting the patient's body.
- Physical examination including a pelvic examination
- Tumor measurements will be done by examination
- Blood tests including chemistry, hematology, and other tests to measure disease status or markers for the patient's cancer
- Blood counts will be repeated every week throughout the patient's treatment. Other tests will be repeated as necessary. If the doctor feels it is necessary, more X-ray tests may be done throughout the study. Results from these check-ups will be submitted to the Gynecology Oncology Group (GOG) for analysis as a part of the study.

Patients will be "randomized" into one of the study groups described below. Randomization means that the patient is put into a group by chance (like the toss of a coin). A computer program will assign the patient to one of the study groups. Neither the patient nor the doctor can choose the group the patient will be in. Patients will have an equal chance of being in either group.

Group I: Participants will receive concurrent (given together) chemotherapy and radiation therapy. The chemotherapy is called Cisplatin and is given intravenously (into a vein) over two hours once every week for six weeks (called cycles). The external radiation therapy is given daily for five weeks. After the external radiation is completed, patients will receive intracavitary radiation (delivered directly to the cervix through the vagina) once or twice over an additional 2 to 3 weeks.

Group II: Participants will receive concurrent chemotherapy and radiation therapy. The chemotherapy will be Cisplatin plus the investigational agent TPZ. Cisplatin and TPZ
are given together over about four hours on days 1, 5, and 29. TPZ is given alone over about two hours on days 8, 10, 12, 22, 24, and 26. On days when they are given together,
the TPZ will be given before the Cisplatin. Patients will also receive radiation therapy as outlined for Group I.

After the patient is finished taking the chemotherapy and radiation (approximately eight weeks after beginning treatment), the study doctor will ask the patient to visit the office for follow-up exams every three months for the first two years, every six months for the next three years, and then annually for the rest of their life. Keeping in touch with the patient and checking on their condition every year helps the researchers examine the long-term effects of the study.

How long will the Study run?

Patients will be in the study for the rest of their life.

Sponsor(s): Gynecology Oncology Group (GOG)

Study Activation/Registration Date: 05/16/2008

IRB Review and Approval Date: 04/30/2008

Study Type: Treatment

Projected Accrual: The plan is to enroll up to 750 patients to 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: Harry Long, 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: 07/11/2008