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Drugs to Reduce the Side Effects of Chemotherapy

NCT ID: NCT00003213

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

1999-08-31

Brief Summary

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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

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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.

Conditions

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Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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unspecified adult solid tumor, protocol specific nausea and vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Study Groups

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Oral Granisetron + Dexamethasone

1 mg Granisetron in the morning

1 Metoclopramide placebo in the afternoon

1 mg Granisetron in the evening 4 mg Dexamethasone in the morning

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

4 mg Dexamethasone in the morning

granisetron hydrochloride

Intervention Type DRUG

1 mg Granisetron in the morning

Metoclopramide + Dexamethasone

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

Group Type EXPERIMENTAL

dexamethasone

Intervention Type DRUG

4 mg Dexamethasone in the morning

metoclopramide hydrochloride

Intervention Type DRUG

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

Interventions

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dexamethasone

4 mg Dexamethasone in the morning

Intervention Type DRUG

granisetron hydrochloride

1 mg Granisetron in the morning

Intervention Type DRUG

metoclopramide hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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dexamethasone acetate Kytril® Metozolv®

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matti S. Aapro, MD

Role: STUDY_CHAIR

European Institute of Oncology

Locations

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Istituto Europeo Di Oncologia

Milan, , Italy

Site Status

Kantonspital Aarau

Aarau, , Switzerland

Site Status

Office of Walter Weber-Stadelman

Basel, , Switzerland

Site Status

University Hospital

Basel, , Switzerland

Site Status

Inselspital, Bern

Bern, , Switzerland

Site Status

Hopital Cantonal Universitaire de Geneva

Geneva, , Switzerland

Site Status

Istituto Oncologico della Svizzera Italiana

Lugano, , Switzerland

Site Status

Burgerspital, Solothurn

Solothurn, , Switzerland

Site Status

City Hospital Triemli

Zurich, , Switzerland

Site Status

Klinik Hirslanden

Zurich, , Switzerland

Site Status

Countries

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Italy Switzerland

References

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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.

Reference Type RESULT
PMID: 12562658 (View on PubMed)

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.

Reference Type RESULT
PMID: 11773155 (View on PubMed)

Other Identifiers

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SWS-SAKK-90/95

Identifier Type: -

Identifier Source: secondary_id

EU-97035

Identifier Type: -

Identifier Source: secondary_id

CDR0000066073

Identifier Type: -

Identifier Source: secondary_id

SAKK 90/95

Identifier Type: -

Identifier Source: org_study_id