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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017809
Recruitment Status : Withdrawn (NYU 03-67 reached accrual prior to this study opening.)
First Posted : November 23, 2009
Last Update Posted : March 18, 2015
Information provided by:
New York University School of Medicine

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 : December 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
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 Name: Emend

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) [ Time Frame: 28 days (1 cycle) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017809

United States, New York
NYU Clinical Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Principal Investigator: Franco Muggia, MD New York University Cancer Institute

Responsible Party: Franco Muggia, MD, New York University Cancer Institute Identifier: NCT01017809     History of Changes
Other Study ID Numbers: NYU 08-851
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by New York University School of Medicine:

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents