Prolonged Emend in a Study (NYU 03-67) of Oxaliplatin and Topotecan in Previously Treated Ovarian Cancer

Not Applicable

Withdrawn

• Conditions: Ovarian Cancer
• Interventions: Drug: Aprepitant

• Registration Number: NCT01017809
• Lead Sponsor: NYU Langone Health

Brief Summary

The investigators propose to totally abolish the emesis (vomiting) associated with the regimen of oxaliplatin + topotecan by adding a daily administration of aprepitant (Emend) for 17 days to the HT3 blocker routinely given on days 1 and 15.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• All patients fulfilling the requirement for entering the study NYU 03-67 will be eligible to enter the supplementary protocol with Emend. Please see NCT0031361 for eligibility.

Exclusion Criteria

• Patients not enrolled on NYU 03-67(NCT0031361).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxali/Topotecan	Aprepitant	Patients enrolled to NYU 03-67 will be receiving Oxaliplatin 85 mg/m2 IV over 120 minutes on Day 1 and 15 Topotecan 0.4mg/m2/day CIV from D1 to 15 (in addition to the assigned intervention)

Primary Outcome Measures

Name	Time	Method
to determine whether daily administration of Emend will prevent emesis during cycle 1 in patients with previously treated ovarian cancer enrolled in NYU 03-67 (oxaliplatin combined with continuous infusion topotecan)	28 days (1 cycle)

Trial Locations

Locations (1)

NYU Clinical Cancer Center; 🇺🇸 New York, New York, United States