Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation

Study Groups:

If you agree to take part in this study, and you are among the first 40 participants, you
will have an equal chance of being in either group. If you enroll after that, you will have a
higher chance (51%-100%) of being assigned to the group that had better results.

- If you are in Group 1, you will receive granisetron by patch.

- If you are in Group 2, you will receive ondansetron by mouth.

Study Drug Administration:

If you are in Group 1, you will receive ondansetron by vein at your first visit only, which
is standard of care. Then, you will receive cisplatin by vein over about 1 hour as part of
the chemoradiation. A granisetron patch will then be placed on your skin before the
chemotherapy . The patch will be replaced every 7 days before the chemotherapy.

If you are in Group 2, you will receive ondansetron by vein before cisplatin. Then, you will
receive cisplatin by vein over about 1 hour. Then you will take ondansetron by mouth with a
cup of water (8 ounces) 3 times a day for 3 days. Ondansetron is a tablet that you can take
with or without food and is best taken at least 30 minutes before eating.

Both groups will be given a study drug diary to record the times that you take the study
drugs. You will also record any nausea or vomiting that you may have. You should bring the
diary to each study visit. You should also bring your study drug bottles/packages to each
study visit.

Study Visits:

The visits for this study will be at the same time as your chemoradiation therapy visits over
5 weeks.

You will complete 3 questionnaires at your study visits and then again 1 week after the last
chemotherapy. The last questionnaires will be completed by phone. The questionnaires ask
about how easy or difficult it is to use your assigned study drug, your level of nausea and
vomiting, and your quality of life. It should take about 5 minutes to complete these
questionnaires each time.

Length of Treatment:

You may continue using the study drug up to 5 weeks during your chemoradiation treatment. You
will no longer be able to take the study drug if the disease gets worse, if intolerable side
effects occur, or if you are unable to follow study directions.

Your participation on the study will be over when you have completed 5 weeks of
chemoradiation treatments.

This is an investigational study. Both granisetron and ondansetron are FDA approved and
commercially available for the treatment of nausea and vomiting. It is investigational to
compare these drugs administered in different ways.

Up to 150 patients will take part in this study. Up to 120 participants will take part at MD
Anderson. Up to 30 will be enrolled at the Harris Health System.

Inclusion Criteria:

1. Women with cervical, endometrial or vaginal cancer dispositioned to receive primary or
postoperative adjuvant pelvic radiation therapy with concurrent cisplatin
administration.

2. Women must be at least 18 years of age.

3. Women must be able to read English or Spanish at a sixth grade level.

4. Women with childbearing potential must have a negative pregnancy test within 1 week of
starting chemoradiation therapy.

Exclusion Criteria:

1. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy
and/or radiation therapy for recurrent disease.

2. Women with cervical, endometrial, or vaginal cancer who are receiving extended field
radiation therapy.

3. Women with cervical, endometrial or vaginal cancer who are receiving chemotherapy
and/or radiation therapy in a palliative setting.

4. Women with cervical, endometrial, or vaginal cancer who have already received their
first dose of chemotherapy or radiation for more than 7 days prior to starting
chemotherapy.