comparison of antiemetic drugs in preventing delayed nausea after chemotherapy in patients with cancer

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

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.

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.

Eligibility 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

Keywords: nausea and vomiting unspecified adult solid tumor, protocol specific