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

Sponsor

NYU Langone Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01017809

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: Aprepitant	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Oxali/Topotecan 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)	Drug: Aprepitant Cycle 1, day 2 to 17: Emend 80mg once daily in the morning on days 2 through 17 Cycles 2-6 (optional extension arm): same Emend dosing Other Names: Emend

Arm

Intervention/Treatment

Other: Oxali/Topotecan

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)

Drug: Aprepitant

Cycle 1, day 2 to 17: Emend 80mg once daily in the morning on days 2 through 17 Cycles 2-6 (optional extension arm): same Emend dosing

Other Names:

Emend

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.