Efficacy of Two Antiemetic Regimens in Patients Receiving Radiotherapy and Concomitant Weekly Cisplatin (GAND-emesis)

This study has been completed.
Sponsor:
Collaborator:
Helsinn Healthcare SA
Information provided by (Responsible Party):
Christina Ruhlmann, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01074697
First received: February 23, 2010
Last updated: April 23, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Nausea
Vomiting
Genital Neoplasms, Female
Drug: Fosaprepitant dimeglumine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode. [ Time Frame: 0-35 days ] [ Designated as safety issue: No ]
  • To compare quality of life using the FLIE questionnaire. [ Time Frame: 0-35 days ] [ Designated as safety issue: No ]
  • To compare tolerability of both regimens. [ Time Frame: 0-35 days ] [ Designated as safety issue: Yes ]

Enrollment: 246
Study Start Date: April 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fosaprepitant dimeglumine Drug: Fosaprepitant dimeglumine
Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.
Other Names:
  • Fosaprepitant dimeglumine
  • Palonosetron
  • Dexamethasone
Placebo Comparator: Saline water Drug: Placebo
Saline water

  Eligibility

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

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.
  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: NCT01074697

Locations
Australia
RAH Cancer Centre, Royal Adelaide Hospital
Adelaide SA, Australia, 5000
Denmark
Department of Oncology
Aarhus, Denmark, 8000
Rigshospitalet, Finsen Centret
Copenhagen, Denmark, 2100
Herlev Hospital
Herlev, Denmark, 2730
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Germany
Vivantes Klinikum Neukolln
Berlin, Germany
Universitatsklinikum Schleswig Holstein
Kiel, Germany, 24105
Norway
The Norwegian Radium Hospital
Oslo, Norway, 0310
Sponsors and Collaborators
Odense University Hospital
Helsinn Healthcare SA
Investigators
Study Director: Jorn Herrstedt, MD, DMSci Odense University Hospital
Principal Investigator: Christina Ruhlmann, MD Odense University Hospial
Principal Investigator: Dorothy Keefe, MD, FRACP Royal Adelaide Hospital
Principal Investigator: Petra Feyer, MD, DMSci Vivantes Klinikum Neukölln in Berlin
Principal Investigator: Thomas Broe Christensen, MD, PhD Herlev Hospital
Principal Investigator: Gunnar Kristensen, MD, PhD Norwegian Radium Hospital
Principal Investigator: Henrik Roed, MD, DMSci The Finsen Centre, Copenhagen University Hospital
Principal Investigator: Felix Hilpert, MD, DMSci University of Schleswig-Holstein
Principal Investigator: Jacob C Lindegaard, MD Department of Oncology,Aarhus University Hospital, Aarhus, Denmark
  More Information

No publications provided

Responsible Party: Christina Ruhlmann, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01074697     History of Changes
Other Study ID Numbers: GAND-emesis, 2009-014691-21
Study First Received: February 23, 2010
Last Updated: April 23, 2015
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Australia: Human Research Ethics Committee
Germany: Ethics Commission
Norway: Ethics Committee

Keywords provided by Odense University Hospital:
Randomized Controlled Trial
Serotonin Agonists
Dexamethasone
Receptors, Neurokinin-1
Radiotherapy
Cisplatin
Prevention & control

Additional relevant MeSH terms:
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Aprepitant
BB 1101
Cisplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fosaprepitant
Palonosetron
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on August 27, 2015