Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SWS-SAKK-90/95 | |||
| EU-97035 | |||
| CDR0000066073 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Metoclopramide + Dexamethasone | Experimental | 20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) 4 mg Dexamethasone in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug | 4 mg Dexamethasone in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete and partial control of emesis | Total control of emesis on every one of the 5 days following the acute phase |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matti S. Aapro, MD | European Institute of Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Europeo Di Oncologia | Milan | 20141 | Italy | |||
| Kantonspital Aarau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12562658 | Result | 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. | |
| 11773155 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| granisetron hydrochloride | Drug | 1 mg Granisetron in the morning |
|
|
| metoclopramide hydrochloride | Drug | 20 mg Metoclopramide (1 x morning, 1 x afternoon, 1 x evening) |
|
|
| Aarau |
| 5001 |
| Switzerland |
| Office of Walter Weber-Stadelman | Basel | CH 4051 | Switzerland |
| University Hospital | Basel | CH-4031 | Switzerland |
| Inselspital, Bern | Bern | CH-3010 | Switzerland |
| Hopital Cantonal Universitaire de Geneva | Geneva | CH-1211 | Switzerland |
| Istituto Oncologico della Svizzera Italiana | Lugano | CH-6900 | Switzerland |
| Burgerspital, Solothurn | Solothurn | 4500 | Switzerland |
| City Hospital Triemli | Zurich | 8063 | Switzerland |
| Klinik Hirslanden | Zurich | CH-8008 | Switzerland |
| 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. |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C018038 | dexamethasone acetate |
| D017829 | Granisetron |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
Not provided
Not provided