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Completed

NCT Number: NCT01012336

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

The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urogenital Neoplasms Vomiting

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient is over 18 years
  • ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy
  • Karnofsky score > 60
  • Life expectancy > 4 months

Exclusion criteria

  • 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)
  • Patients have received a nonapproved drug within last 4 weeks
  • abnormal laboratory values (AST > 2.5 normal, ALT > 2.5 normal, Bilirubin > 1.5 normal, Creatinine > 1.5 normal)
  • Antiemetic drugs within 48 hours of study
  • Benzodiazepine or opiate within 48 hours
  • CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
  • CYP3A4 inhibitors (clarithromycin, ketoconazole)
  • CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)

Treatment and study plan

Aprepitant/Ramosetron/Dexamethasone

Drug

Aprepitant: The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3.

Ramosetron: 0.3 mg i.v. a single dose on day 1, administered over 30 seconds, 30 minutes prior to chemotherapy.

Dexamethasone: 20mg diluted in 50ml of 0.9% saline i.v. a single dose on day 1, administered over 30minutes prior to chemotherapy (taxane). Because all patients are premedicated with dexamethasone 20 mg before taxane administration, the dose of dexamethasone can not be reduced to 12 mg.

Primary outcomes

  1. 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.

    Time frame: 120 hours

    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).

  2. Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen

    Time frame: 120 hours

Secondary outcomes

  1. Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy

    Time frame: 120 hours

  2. Time to First Vomiting Episode or Use of Rescue Medication

    Time frame: 120 hours

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 13, 2009
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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