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

NYU Langone Health

Status: Withdrawn

Conditions: Ovarian Cancer

Treatments: Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT01017809

NYU 08-851

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Oxali/Topotecan

Other group

Description:

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)

Treatment:

Drug: Aprepitant