Know Cancer

or
forgot password

Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin


Phase 2
20 Years
80 Years
Not Enrolling
Female
Chemotherapy-Induced Nausea and Vomiting, Ovarian Cancer

Thank you

Trial Information

Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin

Inclusion Criteria


Inclusion criteria

1. patient is over 18 years

2. ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy

3. Karnofsky score > 60

4. Life expectancy > 4 months

Exclusion criteria

1. Any of following conditions (mentally incapacitated or emotional or psychiatric
disorder, user of any illicit drugs, has an active infection, hypersensitivity to
ramosetron or aprepitant)

2. Patients have received a nonapproved drug within last 4 weeks

3. abnormal laboratory values (AST > 2.5 normal, ALT > 2.5 normal, Bilirubin > 1.5
normal, Creatinine > 1.5 normal)

4. Antiemetic drugs within 48 hours of study

5. Benzodiazepine or opiate within 48 hours

6. CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)

7. CYP3A4 inhibitors (clarithromycin, ketoconazole)

8. CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.

Outcome Description:

Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).

Outcome Time Frame:

120 hours

Safety Issue:

Yes

Principal Investigator

Duk Soo Bae, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

2009-09-119

NCT ID:

NCT01012336

Start Date:

May 2010

Completion Date:

April 2012

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Ovarian Cancer
  • efficacy and safety of Aprepitant/Ramosetron/Dexamethasone in ovary cancer patients with taxol and carboplatin
  • Nausea
  • Vomiting
  • Ovarian Neoplasms

Name

Location