NCT00003213

Brief Summary

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 1996

Typical duration for phase_3

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 1999

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 2, 2004

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

2.9 years

First QC Date

November 1, 1999

Last Update Submit

July 10, 2012

Conditions

Nausea and VomitingUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificnausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • Complete and partial control of emesis

    Total control of emesis on every one of the 5 days following the acute phase

Study Arms (2)

Oral Granisetron + Dexamethasone

EXPERIMENTAL

1 mg Granisetron in the morning 1 Metoclopramide placebo in the afternoon 1 mg Granisetron in the evening 4 mg Dexamethasone in the morning

Drug: dexamethasoneDrug: granisetron hydrochloride

Metoclopramide + Dexamethasone

EXPERIMENTAL

20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) 4 mg Dexamethasone in the morning

Drug: dexamethasoneDrug: metoclopramide hydrochloride

Interventions

dexamethasoneDRUG

4 mg Dexamethasone in the morning

Also known as: dexamethasone acetate
Metoclopramide + DexamethasoneOral Granisetron + Dexamethasone
granisetron hydrochlorideDRUG

1 mg Granisetron in the morning

Also known as: Kytril®
Oral Granisetron + Dexamethasone
metoclopramide hydrochlorideDRUG

20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening)

Also known as: Metozolv®
Metoclopramide + Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Scheduled to receive a first course of highly emetogenic single day cancer chemotherapy regimens including: Cisplatin at least 50 mg/m2 Carboplatin at least 300 mg/m2 Dacarbazine at least 500 mg/m2 Doxorubicin at least 40 mg/m2 Epirubicin at least 60 mg/m2 Ifosfamide at least 1200 mg/m2 Cyclophosphamide at least 600 mg/m2 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete diary card (fluent in German, French, or Italian) No severe concurrent illness No other etiologies that cause vomiting, including: Gastrointestinal obstruction Hypercalcemia CNS metastases No active peptic ulceration No prior gastrointestinal bleeding due to peptic ulcer No moderate to severe nausea or any vomiting in the 24 hours prior to chemotherapy Not pregnant or lactating PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior chemotherapy Concurrent etoposide and fluorouracil allowed (days 1-5) No chemotherapy before day 0 of study Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent antiemetics No concurrent high dose benzodiazepines No concurrent psychotropic agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

Kantonspital Aarau

Aarau, 5001, Switzerland

Location

Office of Walter Weber-Stadelman

Basel, CH 4051, Switzerland

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Hopital Cantonal Universitaire de Geneva

Geneva, CH-1211, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Lugano, CH-6900, Switzerland

Location

Burgerspital, Solothurn

Solothurn, 4500, Switzerland

Location

City Hospital Triemli

Zurich, 8063, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

Related Publications (2)

  • Aapro MS, Thuerlimann B, Sessa C, De Pree C, Bernhard J, Maibach R; Swiss Group for Clinical Cancer Research. A randomized double-blind trial to compare the clinical efficacy of granisetron with metoclopramide, both combined with dexamethasone in the prophylaxis of chemotherapy-induced delayed emesis. Ann Oncol. 2003 Feb;14(2):291-7. doi: 10.1093/annonc/mdg075.

    PMID: 12562658RESULT

  • Bernhard J, Maibach R, Thurlimann B, Sessa C, Aapro MS; Swiss Group for Clinical Cancer Research. Patients' estimation of overall treatment burden: why not ask the obvious? J Clin Oncol. 2002 Jan 1;20(1):65-72. doi: 10.1200/JCO.2002.20.1.65.

    PMID: 11773155RESULT

MeSH Terms

Conditions

NauseaVomiting

Interventions

Dexamethasonedexamethasone acetateGranisetronMetoclopramide

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAzabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzamidesAmidespara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Matti S. Aapro, MD

    European Institute of Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 2, 2004

Study Start

May 1, 1996

Primary Completion

April 1, 1999

Study Completion

August 1, 1999

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

IT(1)CH(9)