Drugs to Reduce the Side Effects of Chemotherapy

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

dexamethasone

granisetron hydrochloride

metoclopramide hydrochloride

About this trial

This is an interventional supportive care trial for Nausea and Vomiting focused on measuring unspecified adult solid tumor, protocol specific, nausea and vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Oral Granisetron + Dexamethasone

Metoclopramide + Dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Complete and partial control of emesis

Secondary Outcome Measures

Full Information

NCT ID

NCT00003213

First Posted

November 1, 1999

Last Updated

July 10, 2012

Sponsor

Swiss Group for Clinical Cancer Research

1. Study Identification

Unique Protocol Identification Number

NCT00003213

Brief Title

Drugs to Reduce the Side Effects of Chemotherapy

Official Title

A Randomized, Double-Blind Trial to Compare the Clinical Efficacy and Safety of Granisetron vs. Metoclopramide Combined to Dexamethasone in the Prophylaxis of Chemotherapy-Induced Delayed Emesis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

May 1996 (undefined)

Primary Completion Date

April 1999 (Actual)

Study Completion Date

August 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

OBJECTIVES: I. Compare the clinical efficacy and safety of Granisetron or Metoclopramide in combination with Dexamethasone in the prophylaxis of delayed nausea and vomiting induced by emetogenic cancer chemotherapy in patients with or without emesis in the acute phase. OUTLINE: This is a randomized, double blind study. Patients are stratified by prior chemotherapy (yes vs no), regular alcohol consumption (yes vs no), and prior chemotherapy regimen (cisplatin/carboplatin vs others). Patients receive dexamethasone and granisetron by mouth bid on day 0. Patients are then randomized to receive either granisetron or metoclopramide with dexamethasone concurrently with chemotherapy. Arm I: Patients receive granisetron by mouth bid on days 1-5. Dexamethasone and a placebo are administered by mouth once daily on days 1-5. Arm II: Patients receive metoclopramide by mouth tid on days 1-5. Dexamethasone is administered by mouth once daily on days 1-5. Patients must complete a diary card daily for 6 days. PROJECTED ACCRUAL: This study will accrue 360 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific, nausea and vomiting

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

267 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Granisetron + Dexamethasone

Arm Type

Experimental

Arm Description

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

Arm Title

Metoclopramide + Dexamethasone

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Other Intervention Name(s)

dexamethasone acetate

Intervention Description

4 mg Dexamethasone in the morning

Intervention Type

Drug

Intervention Name(s)

granisetron hydrochloride

Other Intervention Name(s)

Kytril®

Intervention Description

1 mg Granisetron in the morning

Intervention Type

Drug

Intervention Name(s)

metoclopramide hydrochloride

Other Intervention Name(s)

Metozolv®

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete and partial control of emesis

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matti S. Aapro, MD

Organizational Affiliation

European Institute of Oncology

Official's Role

Study Chair

Facility Information:

Facility Name

Istituto Europeo Di Oncologia

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Kantonspital Aarau

City

Aarau

ZIP/Postal Code

5001

Country

Switzerland

Facility Name

Office of Walter Weber-Stadelman

City

Basel

ZIP/Postal Code

CH 4051

Country

Switzerland

Facility Name

University Hospital

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

Inselspital, Bern

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

Hopital Cantonal Universitaire de Geneva

City

Geneva

ZIP/Postal Code

CH-1211

Country

Switzerland

Facility Name

Istituto Oncologico della Svizzera Italiana

City

Lugano

ZIP/Postal Code

CH-6900

Country

Switzerland

Facility Name

Burgerspital, Solothurn

City

Solothurn

ZIP/Postal Code

4500

Country

Switzerland

Facility Name

City Hospital Triemli

City

Zurich

ZIP/Postal Code

8063

Country

Switzerland

Facility Name

Klinik Hirslanden

City

Zurich

ZIP/Postal Code

CH-8008

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

12562658

Citation

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.

Results Reference

result

PubMed Identifier

11773155

Citation

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.

Results Reference

result

Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial