Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin

Nausea Clinical Trial

— GAND-emesis  

Official title:

A Multinational, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Tolerability of Palonosetron and Dexamethasone Plus Fosaprepitant or Placebo in Patients Receiving Radiotherapy and Weekly Cisplatin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074697
• Other study ID #: GAND-emesis
• Secondary ID: 2009-014691-21
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2010
• Last updated: April 23, 2015
• Start date: April 2010
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research EthicsAustralia: Human Research Ethics CommitteeGermany: Ethics CommissionNorway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.

The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: (abbreviated)

1. The patient has a diagnosis cervical cancer.

2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.

3. The patient is aged > 18 years.

4. The patient must be both chemo- and radiotherapy (RT) naïve. NB: previously low voltage RT or electron RT for non-melanoma skin cancers is allowed.

5. The patient is scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of = 40 mg/m2 for at least five weeks.

6. Brachy therapy is scheduled to be initiated after the third cycle of weekly cisplatin, and preferentially after the fifth week of treatment.

7. Chemotherapy with an emetic risk potential of minimal or mild (up to 30%) is allowed on days 1-4 (see ref. 14).

8. The patient has a WHO Performance Status of = 2.

Exclusion Criteria: (abbreviated)

1. The patient has a current malignant diagnosis other than cervical cancer, with exception of non-melanoma skin cancers.

2. The patient is aged < 18 years.

3. The patient is scheduled to receive less than five weeks of fractionated radiotherapy and concomitant weekly cisplatin.

4. Brachy therapy is planned to be initiated before the third cycle of weekly cisplatin.

5. The patient has been previously treated with radiotherapy, and/or chemotherapy, with exception of treatment with low voltage RT or electron RT for non-melanoma skin cancers .

6. The patient has a WHO Performance Status of > 2.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Nausea
• Vomiting

Intervention

Drug:
• Fosaprepitant dimeglumine
Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.
• Placebo
Saline water

Locations

Country	Name	City	State
Australia	RAH Cancer Centre, Royal Adelaide Hospital	Adelaide SA
Denmark	Department of Oncology	Aarhus
Denmark	Rigshospitalet, Finsen Centret	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Department of Oncology, Odense University Hospital	Odense
Germany	Vivantes Klinikum Neukolln	Berlin
Germany	Universitatsklinikum Schleswig Holstein	Kiel
Norway	The Norwegian Radium Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	Helsinn Healthcare SA

Countries where clinical trial is conducted

Australia,  Denmark,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare fosaprepitant dimeglumine, palonosetron, and dexamethasone with palonosetron, dexamethasone, and placebo with respect to efficacy; the proportion of subjects with no vomiting during five weeks of radiotherapy and concomitant weekly cisplatin.		35 days	No
Secondary	To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with complete response in the 7 days following initiation of radiotherapy and concomitant weekly cisplatin.		7 days	No
Secondary	To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no significant nausea during five weeks of fractionated radiotherapy and concomitant weekly cisplatin at a dose of = 40 mg/m2.		35 days	No
Secondary	To compare the fosaprepitant dimeglumine regimen and the control regimen with respect to complete response in the 35 days following initiation of fractionated radiotherapy and concomitant weekly cisplatin at a dose of = 40 mg/m2.		35 days	No
Secondary	To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no nausea during five weeks (35 days) of fractionated radiotherapy and concomitant weekly cisplatin at a dose of = 40 mg/m2.		35 days	No
Secondary	To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode.		0-35 days	No
Secondary	To compare quality of life using the FLIE questionnaire.		0-35 days	No
Secondary	To compare tolerability of both regimens.		0-35 days	Yes