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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Delayed Nausea: What Works Best?

Conditions
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Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: dolasetron mesylate
* Drug: granisetron hydrochloride
* Drug: ondansetron
* Drug: prochlorperazine
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of cancer for which a chemotherapy regimen containing doxorubicin (with adjuvant, neoadjuvant, curative, or palliative intent) is scheduled Scheduled chemotherapy regimen must not include any of the following: Multiple doses of doxorubicin, dacarbazine, hexamethylmelamine, nitrosoureas, or streptozocin Doxorubicin HydroCloride liposome or cisplatin Scheduled chemotherapy regimen may contain agents, other than those listed above, administered orally, IV, or IV continuously on 1 or multiple days Must be scheduled to receive a 5 hydroxytryptamine 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone concurrently with doxorubicin No clinical evidence of an impending bowel obstruction No symptomatic brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent interferon Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: Concurrent rescue medications (as appropriate) for control of symptoms caused by cancer or its treatment allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dolasetron mesylate|nan|
|Drug: granisetron hydrochloride|nan|
|Drug: ondansetron|nan|
|Drug: prochlorperazine|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, unspecified adult solid tumor, protocol specific