This randomized phase III trial studies ondansetron hydrochloride to see how well it works compared to granisetron transdermal patch in reducing nausea and vomiting in patients with cervical, endometrial, or vaginal cancer receiving radiation therapy and cisplatin. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. It is not yet known whether ondansetron hydrochloride is more effective than granisetron transdermal patch in treating patients with cervical, endometrial, or vaginal cancer receiving radiation therapy and cisplatin.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01536392.
PRIMARY OBJECTIVES:
I. To measure response rates to anti-emetic therapy (no emetic or retching episodes and no rescue medication use) in the late onset phase (days 4-7) of granisetron administered via a transdermal patch compared to orally administered ondansetron (ondansetron hydrochloride) in women with cervical, endometrial, or vaginal cancer undergoing chemoradiation therapy.
SECONDARY OBJECTIVES:
I. To measure response rates to anti-emetic therapy (no emetic or retching episodes and no rescue medication use) in the acute (0-24 hours) and delayed (24-72 hours) phases of granisetron administered via a transdermal patch compared to orally administered ondansetron in women with cervical, endometrial or vaginal cancer undergoing chemoradiation therapy.
II. To measure compliance with granisetron administered via a transdermal patch compared to orally administered ondansetron in women with cervical, endometrial or vaginal cancer undergoing chemoradiation therapy.
III. To measure amount and effect of nausea/vomiting on quality of life with granisetron administered via a transdermal patch compared to orally administered ondansetron in women with cervical, endometrial or vaginal cancer undergoing chemoradiation therapy.
IV. To determine if granisetron administered via a transdermal patch compared to orally administered ondansetron results in less dose reductions of cisplatin in women with cervical, endometrial or vaginal cancer undergoing chemoradiation therapy.
V. To measure amount of “rescue medication” for chemotherapy-induced nausea and vomiting (CINV) during chemoradiotherapy in women with cervical, endometrial or vaginal cancer undergoing chemoradiation therapy taking granisetron administered via a transdermal patch compared to orally administered ondansetron.
TERTIARY OBJECTIVES:
I. Women undergoing definitive chemoradiation therapy for cervical, endometrial or vaginal cancer typically have significant diarrhea as a therapeutic complication. However, 5-hydroxytryptamine3 (5HT3) blockers tend to cause constipation as a medication side effect. Therefore, we hypothesize that women undergoing chemoradiation therapy and receiving the continuous administration of a 5HT3 blocker via the patch (Sancuso) will have less diarrhea than those receiving only 72 hours of scheduled oral 5HT3 blockers (ondansetron).
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP A: Patients receive granisetron transdermal patch every 7 days and ondansetron hydrochloride intravenously (IV) before course 1 of cisplatin IV infusion.
GROUP B: Beginning within 8 hours of cisplatin, patients receive ondansetron hydrochloride orally (PO) thrice daily (TID). Treatment continues for 72 hours after completion of cisplatin.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorMichael M. Frumovitz
