Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis

This study has been terminated.
(we terminated the study before enrolling 303/560 due to a slow accrual)
Sponsor:
Information provided by (Responsible Party):
Roila Fausto, S. Maria Hospital, Terni
ClinicalTrials.gov Identifier:
NCT00869310
First received: March 24, 2009
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

The aim of the study is to compare efficacy and tolerability of aprepitant plus dexamethasone versus metoclopramide plus dexamethasone in the prevention of cisplatin-induced delayed emesis in patients that received aprepitant, palonosetron and dexamethasone before chemotherapy administration for the prevention of acute emesis.


Condition Intervention Phase
Emesis
Drug: aprepitant + dexamethasone
Drug: metoclopramide + dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis: a Double-blind Randomized Trial

Resource links provided by NLM:


Further study details as provided by S. Maria Hospital, Terni:

Primary Outcome Measures:
  • Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after cisplatin administration [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the impact on quality of life of the two antiemetic regimens [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Evaluation of the prognostic factors of delayed emesis in patients receiving a combination of aprepitant, palonosetron, dexamethasone for the prevention of acute emesis [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Enrollment: 303
Study Start Date: September 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dexamethasone plus Aprepitant
Drug: aprepitant + dexamethasone
Dexamethasone 8 mg orally: 24 hours after chemotherapy (day 2) and then at 8 am on days 3-4 plus Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.
Active Comparator: 2
dexamethasone plus metoclopramide
Drug: metoclopramide + dexamethasone
dexamethasone 8 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on days 3-4 plus Metoclopramide 20 mg orally 4 times a day: 24 hours after chemotherapy and then at 4 pm, 7 pm, 10 pm on day 2 then at 7 am, 12 am, 5 pm, 10 pm on days 3-4.

Detailed Description:

This is a phase III, double-blind, randomized trial, to evaluated the efficacy and safety of aprepitant for the prevention of delayed emesis in patients submitted for the first time to chemotherapy with cisplatin.

The study will be carried out during the first cycle of chemotherapy.

For the prevention of acute emesis, all patients will receive, before chemotherapy:

  • dexamethasone 12 mg iv, in 15 minutes, 30 minutes before chemotherapy
  • palonosetron 0.25 mg iv bolus, 30 minutes before chemotherapy
  • aprepitant 125 mg orally, 60 minutes before chemotherapy

After 24 hours from chemotherapy administration, patients will be randomized to receive one of the following antiemetic treatments:

A) dexamethasone 8 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on days 3-4 plus Metoclopramide 20 mg orally 4 times a day: 24 hours after chemotherapy and then at 4 pm, 7 pm, 10 pm on day 2 then at 7 am, 12 am, 5 pm, 10 pm on days 3-4.

B) Dexamethasone 8 mg orally: 24 hours after chemotherapy (day 2) and then at 8 am on days 3-4 plus Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.

The patients will receive prochlorperazine suppositories as rescue medication, for important nausea and vomiting (> 2 episodes) during days 1-5 after chemotherapy.

The patients will receive a diary, which includes a Visual Analogue Scale (VAS) for nausea and vomiting evaluation. All patients will fill out the diary, in which, for 6 consecutive days (days 1-6), patients will report for each day the number of vomiting episodes, the intensity and duration of nausea, any antiemetic rescue medication and any adverse event and its treatment.

In addition, on day 1 before chemotherapy and then on day 6, patients have to fill out the FLIE (Functional Living Index-Emesis), a questionnaire concerning the impact of nausea and vomiting on their quality of life.

Primary end-point is the percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after cisplatin administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. patients receiving for the first time chemotherapy with cisplatin at doses ≥50 mg/m2.
  2. patients over 18 years old and those who signed informed consent
  3. adequate contraception if premenopausal women.

Every other anticancer drug in the first 24 hours will be administered after the end of cisplatin.

Exclusion Criteria:

  1. patients receiving other anticancer drugs on days 2-4, except 5-fluorouracil, VP16, VM26, vincristine, vinblastine, vindesine, vinorelbine, gemcitabine
  2. patients already submitted to chemotherapy with cisplatin
  3. patients with concomitant severe diseases, other than neoplasm, or with predisposition to emesis such as intestinal obstruction, active peptic ulcer, hypercalcemia and brain metastases
  4. contraindications to corticosteroids (i.e., active peptic ulcer or previous bleeding from peptic ulcer
  5. patients submitted to concomitant radiotherapy or submitted to radiotherapy in the 15 days before chemotherapy or planned to receive radiotherapy during the 8 days after chemotherapy
  6. patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy
  7. patients with nausea or vomiting in the 24 hours before chemotherapy
  8. patients receiving concomitant steroids, except when administered at physiologic dose
  9. patients receiving concomitant benzodiazepines, except when used for nocturnal sedation
  10. patients with WBC count <3000/mm3 or platelet count <70000/mm3
  11. patients who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869310

Locations
Italy
Fausto Roila
Terni, Italy, 05100
Sponsors and Collaborators
S. Maria Hospital, Terni
Investigators
Principal Investigator: Fausto Roila, MD Oncology Division, S. Maria Hospital, Terni, Italy
  More Information

Publications:

Responsible Party: Roila Fausto, Dr, S. Maria Hospital, Terni
ClinicalTrials.gov Identifier: NCT00869310     History of Changes
Other Study ID Numbers: IGAR-01-2009, 2008-001339-37
Study First Received: March 24, 2009
Last Updated: January 3, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by S. Maria Hospital, Terni:
aprepitant
delayed emesis
cisplatin
antiemetic

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Cisplatin
Dexamethasone
Dexamethasone acetate
Metoclopramide
Aprepitant
Fosaprepitant
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists

ClinicalTrials.gov processed this record on August 19, 2014