Trial Information

Pilot Study Exploring the Efficacy of Prolonged Emend to Reduce Nausea and Vomiting During Treatment in a Phase II Study (NYU 03-67) of Oxaliplatin Combined With Continuous Infusion Topotecan for Patients With Previously Treated Ovarian Cancer

Patients enrolled in NCT0031361, NYU 03-67 (A Phase II study of Oxaliplatin combined with
continuous infusion topotecan as chemotherapy for patients with previously treated ovarian
cancer NCI #6317) will receive oxaliplatin 85mg/m2 as a 2-hr IV infusion on D1, 15 and
topotecan 0.4mg/m2/day as a continuous infusion for 14 days beginning on D1 (D1-15) on a 4
week cycle.

On days 1 and 15 of the first cycle, patients will also receive IV ondansetron 32 mg and
10mg of dexamethasone. Emend 125 mg will be given on day 1; on days 2-17, patients will be
given daily oral 80mg Emend without dexamethasone.

On cycles 2-6 patients opting to continue to receive Emend as above: Emend 125 mg will be
given on day 1; on days 2-17, patients will be given daily oral 80mg Emend without
dexamethasone.

Following cycle 1, Emend will be given in its conventional schedule (i.e., d 1-3, and d
15-17) unless after discussion with the Principal Investigator, the patient's request to
receive drug as in cycle 1 is deemed desirable and safe to enter the optional extension arm.