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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


N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

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.


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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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)

Outcome Time Frame:

28 days (1 cycle)

Safety Issue:

No

Principal Investigator

Franco Muggia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

NYU 08-851

NCT ID:

NCT01017809

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Ovarian Cancer
  • ovarian
  • chemotherapy
  • nausea
  • Ovarian Neoplasms

Name

Location

NYU Clinical Cancer CenterNew York, New York  10016