Drugs to Reduce the Side Effects of Chemotherapy
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| ClinicalTrials.gov Identifier: NCT00003213 |
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Recruitment Status :
Completed
First Posted : August 2, 2004
Last Update Posted : July 11, 2012
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific | Drug: dexamethasone Drug: granisetron hydrochloride Drug: metoclopramide hydrochloride | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 267 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Supportive Care |
| 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 Start Date : | May 1996 |
| Actual Primary Completion Date : | April 1999 |
| Actual Study Completion Date : | August 1999 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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 |
Drug: dexamethasone
4 mg Dexamethasone in the morning
Other Name: dexamethasone acetate Drug: granisetron hydrochloride 1 mg Granisetron in the morning
Other Name: Kytril® |
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Experimental: Metoclopramide + Dexamethasone
20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) 4 mg Dexamethasone in the morning
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Drug: dexamethasone
4 mg Dexamethasone in the morning
Other Name: dexamethasone acetate Drug: metoclopramide hydrochloride 20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening)
Other Name: Metozolv® |
- Complete and partial control of emesis [ Time Frame: Total control of emesis on every one of the 5 days following the acute phase ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003213
| Italy | |
| Istituto Europeo Di Oncologia | |
| Milano, Italy, 20141 | |
| Switzerland | |
| Kantonspital Aarau | |
| Aarau, Switzerland, 5001 | |
| Office of Walter Weber-Stadelman | |
| Basel, Switzerland, CH 4051 | |
| University Hospital | |
| Basel, Switzerland, CH-4031 | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Hopital Cantonal Universitaire de Geneva | |
| Geneva, Switzerland, CH-1211 | |
| Istituto Oncologico della Svizzera Italiana | |
| Lugano, Switzerland, CH-6900 | |
| Burgerspital, Solothurn | |
| Solothurn, Switzerland, 4500 | |
| City Hospital Triemli | |
| Zurich, Switzerland, 8063 | |
| Klinik Hirslanden | |
| Zurich, Switzerland, CH-8008 | |
| Study Chair: | Matti S. Aapro, MD | European Institute of Oncology |
| Responsible Party: | Swiss Group for Clinical Cancer Research |
| ClinicalTrials.gov Identifier: | NCT00003213 |
| Other Study ID Numbers: |
SAKK 90/95 SWS-SAKK-90/95 EU-97035 CDR0000066073 |
| First Posted: | August 2, 2004 Key Record Dates |
| Last Update Posted: | July 11, 2012 |
| Last Verified: | July 2012 |
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unspecified adult solid tumor, protocol specific nausea and vomiting |
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Nausea Vomiting Signs and Symptoms, Digestive Dexamethasone Dexamethasone acetate Metoclopramide Granisetron BB 1101 Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Serotonin Antagonists Serotonin Agents |