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Treatment of Delayed Nausea: What Works Best?


Phase 3
18 Years
N/A
Not Enrolling
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Treatment of Delayed Nausea: What Works Best?


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Gary R. Morrow, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068694

NCT ID:

NCT00020657

Start Date:

July 2001

Completion Date:

October 2004

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified adult solid tumor, protocol specific
  • Nausea
  • Vomiting

Name

Location

MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Northern New JerseyHackensack, New Jersey  07601
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
MBCCOP - Gulf CoastMobile, Alabama  36688
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259