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Withdrawn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)
0
1
1
36
0

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
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
  • Outcome Measures

    Primary Outcome Measures

    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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Clinical Cancer Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Franco Muggia, MD, New York University Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01017809
    Other Study ID Numbers:
    • NYU 08-851
    First Posted:
    Nov 23, 2009
    Last Update Posted:
    Mar 18, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 18, 2015