Colon Cancer Clinical Trial
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
Summary
RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting.
PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.
Full Description
OBJECTIVES:
Evaluate the rate of complete responses, defined as no vomiting and no nausea, in patients with primary gastrointestinal and/or retroperitoneal sarcomas treated with two different dosing schedules of palonosetron hydrochloride during abdominal radiotherapy as part of their cancer treatment.
Determine the tolerability of palonosetron hydrochloride vs placebo in these patients.
Validate patient diaries for assessing nausea and vomiting by comparing with alternative methods for measuring nausea and vomiting in order to determine the optimal approach for future studies.
OUTLINE: Patients are stratified according to planned radiotherapy duration (< 5 weeks vs ≥ 5 weeks), planned concurrent fluorouracil ( yes vs no), and gender. Patients are randomized to 1 of 4 treatment arms.
Arm I: Patients receive palonosetron hydrochloride IV on day 1.
Arm II: Patients receive palonosetron hydrochloride IV on days 1 and 4.
Arm III: Patients receive placebo IV on day 1.
Arm IV: Patients receive placebo IV on days 1 and 4. In all arms, courses repeat weekly during radiotherapy in the absence of disease progression or unacceptable toxicity.
Patients complete nausea and vomiting questionnaires and diaries at baseline and daily during radiotherapy. Patients also complete symptom experience diaries weekly during radiotherapy.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma
Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen
Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm^2
No brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception
Able to complete questionnaire(s) alone or with assistance
Willing to return to NCCTG enrolling institution for follow-up
Able to reliably take oral medication (for purposes of rescue medication)
No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor antagonists
No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
No nausea ≤ 48 hours prior to study enrollment
No history of dystonic reactions to prochlorperazine or haloperidol or related agents
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 7 days since prior agents known to have significant effects on emesis, including the following:
Ondansetron
Sedating antihistamines
Antipsychotics
Cannabinoids
Corticosteroids
Metoclopramide
Narcotic analgesics
Benzodiazepines
More than 7 days since prior chemotherapy other than fluorouracil or capecitabine used as a radiosensitizer
More than 7 days since of prior cetuximab
More than 7 days since prior and no concurrent oral steroids
No prior palonosetron hydrochloride
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There are 51 Locations for this study
Scottsdale Arizona, 85259, United States
Jacksonville Florida, 32224, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46515, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Plymouth Indiana, 46563, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
Westville Indiana, 46391, United States
Bettendorf Iowa, 52722, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
Wichita Kansas, 67214, United States
Niles Michigan, 49120, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Fergus Falls Minnesota, 56537, United States
Rochester Minnesota, 55905, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68131, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58502, United States
Grand Forks North Dakota, 58201, United States
Danville Pennsylvania, 17822, United States
Wilkes-Barre Pennsylvania, 18711, United States
Rapid City South Dakota, 57701, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Manitowoc Wisconsin, 54221, United States
Marinette Wisconsin, 54143, United States
Sturgeon Bay Wisconsin, 54235, United States
Sturgeon Bay Wisconsin, 54235, United States
Casper Wyoming, 82609, United States
Sheridan Wyoming, 82801, United States
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