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EmesisPhase 3NCT00869973

Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients

A Phase 3 study testing Aprepitant and dexamethasone in people with Emesis, run by S. Maria Hospital, Terni at 1 site in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of the study is to compare efficacy and tolerability of aprepitant versus dexamethasone in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide plus anthracyclines) in breast cancer patients. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Emesis
What is being tested?
Aprepitant and dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
580 participants
Where
1 siteItaly
Study dates
Sep 2009to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with breast cancer, receiving for the first time chemotherapy with cyclophosphamide + anthracyclines (FAC, FEC, AC, EC).
  • 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 cyclophosphamide plus anthracycline.

Who cannot join

  • patients already submitted to chemotherapy
  • patients receiving any chemotherapy on days 2-4 after treatment
  • patients with concomitant severe diseases 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
Show all 11Show fewer
  • patients with nausea or vomiting in the 24 hours before chemotherapy
  • patients receiving concomitant steroids, except when administered at physiologic doses
  • 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 or breast-feeding

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fausto Roila

    Terni, Terni, 05100

Other trials in Italy

About this study

Official title: Aprepitant in the Prevention of Delayed Emesis Induced by Moderately Emetogenic Chemotherapy (Cyclophosphamide Plus Anthracyclines) in Breast Cancer Patients: a Double-blind Randomized Study

The aim of the study is to compare efficacy and tolerability of aprepitant versus dexamethasone in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide plus anthracyclines) in breast cancer patients.

Read the 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 with breast cancer submitted for the first time to chemotherapy with cyclophosphamide plus anthracyclines.

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 8 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:

  1. dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3.
  2. 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 will 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 chemotherapy administration

Conditions
Emesis
Being tested
Aprepitant, dexamethasone
Keywords
aprepitant, delayed emesis, cyclophosphamide plus anthracyclines, breast cancer, antiemetic
Medical subject headings
Vomiting, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AprepitantDrug

    Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3

  • dexamethasoneDrug

    dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3

Study groups in NCT00869973
Study groupRoleWhat they receive
1ExperimentalAprepitant
Receives: Drug: Aprepitant
2Active comparatordexamethasone
Receives: Drug: dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration

    Measured: 6 days

Secondary outcomes (2)

  1. Evaluation of the impact on quality of life of the two antiemetic regimens

    Measured: 6 days

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

    Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Why it stopped: We terminated the study after enrolling 580/900 patients due to a slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00869973
Sponsor's protocol ID
IGAR-02-2009
Other IDs
2008-001237-95, 2008
Status last verified
Oct 2009
First submitted
25 Mar 2009
Last updated
23 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • Warr DG, Hesketh PJ, Gralla RJ, Muss HB, Herrstedt J, Eisenberg PD, Raftopoulos H, Grunberg SM, Gabriel M, Rodgers A, Bohidar N, Klinger G, Hustad CM, Horgan KJ, Skobieranda F. Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol. 2005 Apr 20;23(12):2822-30. doi: 10.1200/JCO.2005.09.050.

    PubMed 15837996

  • 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.

    PubMed 16314401

  • Eisenberg P, Figueroa-Vadillo J, Zamora R, Charu V, Hajdenberg J, Cartmell A, Macciocchi A, Grunberg S; 99-04 Palonosetron Study Group. Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist: results of a phase III, single-dose trial versus dolasetron. Cancer. 2003 Dec 1;98(11):2473-82. doi: 10.1002/cncr.11817.

    PubMed 14635083

  • Gralla R, Lichinitser M, Van Der Vegt S, Sleeboom H, Mezger J, Peschel C, Tonini G, Labianca R, Macciocchi A, Aapro M. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with ondansetron. Ann Oncol. 2003 Oct;14(10):1570-7. doi: 10.1093/annonc/mdg417.

    PubMed 14504060

  • Italian Group For Antiemetic Research. Randomized, double-blind, dose-finding study of dexamethasone in preventing acute emesis induced by anthracyclines, carboplatin, or cyclophosphamide: J Clin Oncol. 2004 Feb 15;22(4):725-9. doi: 10.1200/JCO.2004.09.040.

    PubMed 14966097

  • Italian Group for Antiemetic Research. Dexamethasone alone or in combination with ondansetron for the prevention of delayed nausea and vomiting induced by chemotherapy. N Engl J Med. 2000 May 25;342(21):1554-9. doi: 10.1056/NEJM200005253422102.

    PubMed 10824073

  • Roila F, Ruggeri B, Ballatori E, Del Favero A, Tonato M. Aprepitant versus dexamethasone for preventing chemotherapy-induced delayed emesis in patients with breast cancer: a randomized double-blind study. J Clin Oncol. 2014 Jan 10;32(2):101-6. doi: 10.1200/JCO.2013.51.4547. Epub 2013 Dec 9.

    PubMed 24323030

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aprepitant and dexamethasone in people with Emesis, run by S. Maria Hospital, Terni at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: We terminated the study after enrolling 580/900 patients due to a slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration (time frame: 6 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00869973, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.

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