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



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

For Condition: unspecified adult solid tumor, protocol specific,Quality of Life,nausea and vomiting
Status: Recruiting
Sponsor(s): James P. Wilmot Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
GaryMorrow,  Study Chair,  James P. Wilmot Cancer Center

CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver,  Colorado,  80224
United States
Recruiting Eduardo  Pajon 303-777-2663

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting J.  Kuebler 614-488-2118

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

CCOP - Northwest *Recruiting*
Tacoma,  Washington,  98405-0986
United States
Recruiting Lauren  Colman 253-403-1677

CCOP - North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Vincent  Vinciguerra 516-562-8915

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

CCOP - Greenville *Recruiting*
Greenville,  South Carolina,  29615
United States
Recruiting Jeffrey  Giguere 864-241-6251

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134

MBCCOP - Gulf Coast *Recruiting*
Mobile,  Alabama,  36688
United States
Recruiting Marcel  Conrad 251-435-3941

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-832-1093

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

CCOP - Northern New Jersey *Recruiting*
Hackensack,  New Jersey,  07601
United States
Recruiting Richard  Rosenbluth 201-996-5900

CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale,  Arizona,  85259-5404
United States
Recruiting Tom  Fitch 480-301-9875

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6600


Additional Information:
Study ID Numbers:
  CDR0000068694;  NCI-P01-0180,URCC-U3901
Study Start Date: 
Record last reviewed: August 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020657

Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer

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

3. Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy

4. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer

5. Ondansetron With or Without Dexamethasone to Prevent Vomiting in Patients Receiving Radiation Therapy to the Upper Abdomen

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

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