Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis

NCT00869310 | Terminated Phase 3

• 2 other identifiers: IGAR-01-20092008-001339-37
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emesis

Keywords

aprepitant; delayed emesis; cisplatin; antiemetic

Outcome Measures

Primary Outcomes (1)

• Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after cisplatin administration

  6 days

Secondary Outcomes (2)

• Evaluation of the impact on quality of life of the two antiemetic regimens

  6 days

• Evaluation of the prognostic factors of delayed emesis in patients receiving a combination of aprepitant, palonosetron, dexamethasone for the prevention of acute emesis

  6 days

Study Arms (2)

1

EXPERIMENTAL

Dexamethasone plus Aprepitant

Drug: aprepitant + dexamethasone

2

ACTIVE COMPARATOR

dexamethasone plus metoclopramide

Drug: metoclopramide + dexamethasone

Interventions

aprepitant + dexamethasone DRUG

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.

1

metoclopramide + dexamethasone DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients receiving for the first time chemotherapy with cisplatin at doses ≥50 mg/m2.
• patients over 18 years old and those who signed informed consent
• adequate contraception if premenopausal women.
• Every other anticancer drug in the first 24 hours will be administered after the end of cisplatin.

You may not qualify if:

• patients receiving other anticancer drugs on days 2-4, except 5-fluorouracil, VP16, VM26, vincristine, vinblastine, vindesine, vinorelbine, gemcitabine
• patients already submitted to chemotherapy with cisplatin
• patients with concomitant severe diseases, other than neoplasm, or with predisposition to emesis such as intestinal obstruction, active peptic ulcer, hypercalcemia and brain metastases
• contraindications to corticosteroids (i.e., active peptic ulcer or previous bleeding from peptic ulcer
• 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
• patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy
• patients with nausea or vomiting in the 24 hours before chemotherapy
• patients receiving concomitant steroids, except when administered at physiologic dose
• patients receiving concomitant benzodiazepines, except when used for nocturnal sedation
• patients with WBC count \<3000/mm3 or platelet count \<70000/mm3
• patients who are pregnant

Sponsors & Collaborators

• S. Maria Hospital, Terni: lead

Study Sites (1)

Fausto Roila

Terni, Terni, 05100, Italy

Location

Related Publications (8)

• Hesketh PJ. Potential role of the NK1 receptor antagonists in chemotherapy-induced nausea and vomiting. Support Care Cancer. 2001 Jul;9(5):350-4. doi: 10.1007/s005200000199.

  PMID: 11497388 RESULT

• Poli-Bigelli S, Rodrigues-Pereira J, Carides AD, Julie Ma G, Eldridge K, Hipple A, Evans JK, Horgan KJ, Lawson F; Aprepitant Protocol 054 Study Group. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer. 2003 Jun 15;97(12):3090-8. doi: 10.1002/cncr.11433.

  PMID: 12784346 RESULT

• Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, Chawla SP, Carides AD, Ianus J, Elmer ME, Evans JK, Beck K, Reines S, Horgan KJ; Aprepitant Protocol 052 Study Group. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group. J Clin Oncol. 2003 Nov 15;21(22):4112-9. doi: 10.1200/JCO.2003.01.095. Epub 2003 Oct 14.

  PMID: 14559886 RESULT

• Roila F, Hesketh PJ, Herrstedt J; Antiemetic Subcommitte of the Multinational Association of Supportive Care in Cancer. Prevention of chemotherapy- and radiotherapy-induced emesis: results of the 2004 Perugia International Antiemetic Consensus Conference. Ann Oncol. 2006 Jan;17(1):20-8. doi: 10.1093/annonc/mdj078. Epub 2005 Nov 28.

  PMID: 16314401 RESULT

• Chawla SP, Grunberg SM, Gralla RJ, Hesketh PJ, Rittenberg C, Elmer ME, Schmidt C, Taylor A, Carides AD, Evans JK, Horgan KJ. Establishing the dose of the oral NK1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting. Cancer. 2003 May 1;97(9):2290-300. doi: 10.1002/cncr.11320.

  PMID: 12712486 RESULT

• Aapro MS, Grunberg SM, Manikhas GM, Olivares G, Suarez T, Tjulandin SA, Bertoli LF, Yunus F, Morrica B, Lordick F, Macciocchi A. A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol. 2006 Sep;17(9):1441-9. doi: 10.1093/annonc/mdl137. Epub 2006 Jun 9.

  PMID: 16766588 RESULT

• Ondansetron versus metoclopramide, both combined with dexamethasone, in the prevention of cisplatin-induced delayed emesis. The Italian Group for Antiemetic Research. J Clin Oncol. 1997 Jan;15(1):124-30. doi: 10.1200/JCO.1997.15.1.124.

  PMID: 8996133 RESULT

• Roila F, Ruggeri B, Ballatori E, Fatigoni S, Caserta C, Licitra L, Mirabile A, Ionta MT, Massidda B, Cavanna L, Palladino MA, Tocci A, Fava S, Colantonio I, Angelelli L, Ciuffreda L, Fasola G, Zerilli F. Aprepitant versus metoclopramide, both combined with dexamethasone, for the prevention of cisplatin-induced delayed emesis: a randomized, double-blind study. Ann Oncol. 2015 Jun;26(6):1248-1253. doi: 10.1093/annonc/mdv132. Epub 2015 Mar 5.

  PMID: 25743855 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant; Dexamethasone; Metoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Fausto Roila, MD

  Oncology Division, S. Maria Hospital, Terni, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

IT (1)