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

PURPOSE: Randomizedphase III trial to compare the effectiveness of different antiemetic drugs in preventing delayed nausea after chemotherapy in patients who have cancer.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific nausea and vomiting Quality of Life	Drug: dolasetron mesylate  Drug: granisetron  Drug: ondansetron  Drug: prochlorperazine  Procedure: nausea and vomiting therapy  Procedure: quality-of-life assessment  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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, hexamethylamine, nitrosoureas, or streptozocin
• Doxorubicin HCl 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

Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States
Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States
Colorado
      CCOP - Colorado Cancer Research Program, Incorporated, Denver,  Colorado,  80224,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
Ohio
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States
South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States
Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

Study chairs or principal investigators

Gary R. Morrow, PhD, MS,  Study Chair,  James P. Wilmot Cancer Center   

Study ID Numbers:  CDR0000068694; URCC-U3901; NCI-P01-0180
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020657
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08