Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
nausea and vomiting, unspecified adult solid tumor, protocol specific
Brief summary
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
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Gary Morrow
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed