Symptoms and General Pathology

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Nausea

Vomiting

Signs and Symptoms, Digestive

Antiemetics

Gastrointestinal Agents

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Anti-Inflammatory Agents

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Granisetron

Dexamethasone

Dexamethasone acetate

BB 1101

Metoclopramide

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Hormone Antagonists

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HIV Protease Inhibitors

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Dopamine Antagonists

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Serotonin

Serotonin 5-HT3 Receptor Antagonists

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

dexamethasone

granisetron hydrochloride

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

metoclopramide hydrochloride

Matti S. Aapro, MD

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.

Drugs to Reduce the Side Effects of Chemotherapy

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

Swiss Group for Clinical Cancer Research

Dermatologic Agents

Central Nervous System Depressants

Psychotropic Drugs

Ondansetron

Prochlorperazine

Dolasetron

Antipsychotic Agents

dolasetron mesylate

ondansetron

prochlorperazine

quality-of-life assessment

Gary R. Morrow, PhD, MS

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients being treated with chemotherapy.

PURPOSE: This randomized phase III trial is comparing how well different antiemetic drugs work in preventing delayed nausea after chemotherapy in patients who have cancer.

OBJECTIVES:

* Compare the effectiveness of a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic vs prochlorperazine in controlling delayed nausea after chemotherapy in patients with chemotherapy-naive cancer.
* Compare the effectiveness of prochlorperazine administered on a preventive vs as needed basis in controlling delayed nausea after chemotherapy in these patients.
* Compare the quality of life of patients treated with a 5-HT3 receptor antagonist antiemetic vs prochlorperazine.
* Compare the quality of life of patients treated with prochlorperazine administered on a preventive vs as needed basis.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.

Patients receive their scheduled chemotherapy regimen containing doxorubicin and their scheduled oral 5 hydroxytryptamine 3 receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) combined with dexamethasone on day 1.

Patients are then randomized to 1 of 3 antiemetic arms.

* Arm I: Patients receive oral prochlorperazine every 8 hours on days 2 and 3.
* Arm II: Patients receive oral ondansetron every 12 hours, oral granisetron every 12 hours, or oral dolasetron mesylate either once a day or every 12 hours on days 2 and 3.
* Arm III: Patients receive oral prochlorperazine as needed, up to 4 times per day, on days 2 and 3.

Quality of life is assessed at baseline and on day 4.

PROJECTED ACCRUAL: A total of 670 patients will be accrued for this study within 3 years.

Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer

Treatment of Delayed Nausea: What Works Best?

National Cancer Institute (NCI)

Gary Morrow

Director, University of Rochester NCORP Research Base

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Breast Neoplasms

Breast Neoplasms, Male

Inflammatory Breast Neoplasms

Breast Cancer, Male

Inflammatory Breast Cancer

Palonosetron

Fosaprepitant

Aprepitant

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.

Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.

Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.

Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

aprepitant

palonosetron hydrochloride

placebo

Joseph A. Roscoe, PhD

RATIONALE: Antiemetic drugs, such as granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron, may help lessen or prevent nausea. It is not yet known which combination of antiemetic drugs is more effective in preventing nausea caused by chemotherapy.

PURPOSE: This randomized phase III trial is comparing different combinations of granisetron, dexamethasone, prochlorperazine, aprepitant, and palonosetron to see how well they work in preventing nausea in patients undergoing chemotherapy for breast cancer.

OBJECTIVES:

Primary

* Compare the efficacy of palonosetron hydrochloride and dexamethasone followed by prochlorperazine with vs without dexamethasone in preventing delayed nausea in women with chemotherapy-naive breast cancer. (Arms I and IV)
* Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride in controlling treatment-related delayed nausea in these patients. (Arms I and II)
* Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for controlling treatment-related delayed nausea in these patients. (Arms III and IV)

Secondary

* Determine if the addition of dexamethasone to prochlorperazine is more effective than the same regimen without dexamethasone for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and IV)
* Determine if palonosetron hydrochloride is more effective than granisetron hydrochloride for reducing interference with functioning caused by chemotherapy-induced nausea and vomiting in these patients. (Arms I and II)
* Determine if the currently recommended antiemetic guideline of aprepitant combined with palonosetron hydrochloride and dexamethasone is the most effective antiemetic regimen for reducing interference with functioning due to chemotherapy-induced nausea and vomiting in these patients. (Arms III and IV)

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to CCOP center and gender. Patients are randomized to 1 of 4 treatment arms. Patients receive study treatment approximately 30 minutes before their scheduled first chemotherapy treatment.

* Arm I: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
* Arm II: Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.
* Arm III: Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.
* Arm IV: Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

Quality of life is assessed at baseline and on day 4. Nausea and vomiting, fatigue, sleep quality, exercise, and the need for rescue medication (metoclopramide) are assessed on days 1-4.

PROJECTED ACCRUAL: A total of 890 patients will be accrued for this study.

Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

1=not at all nauseated to 7=extremely nauseated, therefore higher values are worse

Joseph Roscoe

Research Associate Professor

Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.

placebo : Given orally

prochlorperazine : Given orally or IV

granisetron hydrochloride : Given orally or IV

dexamethasone : Given orally or IV

Arm II

Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.

placebo : Given orally

aprepitant : Given orally or IV

palonosetron hydrochloride : Given orally or IV

dexamethasone : Given orally or IV

Arm III

Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.

placebo : Given orally

prochlorperazine : Given orally or IV

palonosetron hydrochloride : Given orally or IV

dexamethasone : Given orally or IV

Arm I

Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.

placebo : Given orally

prochlorperazine : Given orally or IV

palonosetron hydrochloride : Given orally or IV

dexamethasone : Given orally or IV

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Drugs to Reduce the Side Effects of Chemotherapy	NCT00003213	Nausea and Vomi... Unspecified Adu...	dexamethasone granisetron hyd... metoclopramide ...	18 Years -	Swiss Group for Clinical Cancer Research
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	NCT00020657	Nausea and Vomi... Unspecified Adu...	dolasetron mesy... granisetron hyd... ondansetron prochlorperazin... quality-of-life...	18 Years - 120 Years	University of Rochester
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer	NCT00020657	Nausea and Vomi... Unspecified Adu...	dolasetron mesy... granisetron hyd... ondansetron prochlorperazin... quality-of-life...	18 Years - 120 Years	University of Rochester
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial	NCT00475085	Nausea	aprepitant dexamethasone granisetron hyd... palonosetron hy... prochlorperazin... placebo	18 Years -	University of Rochester
Drugs to Reduce the Side Effects of Chemotherapy	NCT00003213	Nausea and Vomi... Unspecified Adu...	dexamethasone granisetron hyd... metoclopramide ...	18 Years -	Swiss Group for Clinical Cancer Research

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