Oral Versus Transdermal Ondansetron for Women With Cervical Cancer Receiving Chemoradiation

• Response to Anti-Emetic Therapy [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy.
  
  

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 138 participants will take part at MD Anderson. Up to 12 participants will take part at Lyndon B. Johnson General Hospital.