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| Sponsor: | New York University School of Medicine |
|---|---|
| Information provided by: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01017809 |
Purpose
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 | Intervention |
|---|---|
|
Ovarian Cancer |
Drug: Aprepitant |
| Study Type: | Interventional |
| Study Design: | Prevention, Open Label, Single Group Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Franco Muggia, MD | 212-263-6485 | franco.muggia@nyumc.org |
| United States, New York | |
| NYU Clinical Cancer Center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Franco Muggia, MD | New York University Cancer Institute |
More Information
| Responsible Party: | New York University Cancer Institute ( Franco Muggia, MD ) |
| Study ID Numbers: | NYU 08-851 |
| Study First Received: | November 19, 2009 |
| Last Updated: | November 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT01017809 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
ovarian chemotherapy nausea |
|
Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Gastrointestinal Agents Genital Neoplasms, Female Antiemetics Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Pharmacologic Actions |
Adnexal Diseases Genital Diseases, Female Neoplasms Oxaliplatin Neoplasms by Site Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents Endocrine Gland Neoplasms Aprepitant |
