NCT01017809

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

November 19, 2009

Last Update Submit

March 16, 2015

Conditions

Ovarian Cancer

Keywords

ovarianchemotherapynausea

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Oxali/Topotecan

OTHER

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

Interventions

AprepitantDRUG

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

Also known as: Emend
Oxali/Topotecan

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsNausea

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Franco Muggia, MD

    New York University Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 23, 2009

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)