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.

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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.

View Eligibility Criteria

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

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT00903396

Recruitment Status:

Terminated

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 51 Locations for this study

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Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline Illinois, 61265, United States

Moline Illinois, 61265, United States
Elkhart Clinic, LLC
Elkhart Indiana, 46514, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart Indiana, 46514, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Howard Community Hospital
Kokomo Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte Indiana, 46350, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka Indiana, 46545, United States
Saint Joseph Regional Medical Center
Mishawaka Indiana, 46545, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth Indiana, 46563, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
South Bend Clinic
South Bend Indiana, 46617, United States
Michiana Hematology Oncology PC - La Porte
Westville Indiana, 46391, United States

Bettendorf Iowa, 52722, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Michiana Hematology Oncology PC - Niles
Niles Michigan, 49120, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph Michigan, 49085, United States
Duluth Clinic Cancer Center - Duluth
Duluth Minnesota, 55805, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth Minnesota, 55805, United States
Fergus Falls Medical Group, PA
Fergus Falls Minnesota, 56537, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59102, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
Bismarck Cancer Center
Bismarck North Dakota, 58501, United States
Medcenter One Hospital Cancer Care Center
Bismarck North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck North Dakota, 58502, United States
Altru Cancer Center at Altru Hospital
Grand Forks North Dakota, 58201, United States
Geisinger Cancer Institute at Geisinger Health
Danville Pennsylvania, 17822, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre Pennsylvania, 18711, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54301, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse Wisconsin, 54601, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc Wisconsin, 54221, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette Wisconsin, 54143, United States
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay Wisconsin, 54235, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay Wisconsin, 54235, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT00903396

Recruitment Status:

Terminated

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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