Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

Colorectal Cancer Clinical Trial

Official title:

A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00903396
• Other study ID #: NCCTG-N08C2
• Secondary ID: NCI-2009-01109CD
• Status: Terminated
• Phase: Phase 2
• First received: May 15, 2009
• Last updated: October 20, 2017
• Start date: September 2009
• Est. completion date: May 2013

Study information

• Verified date: October 2017
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Appendiceal Neoplasms
• Bile Duct Neoplasms
• Carcinoid Tumor
• Carcinoma of the Appendix
• Cholangiocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Gastrointestinal Carcinoid Tumor
• Gastrointestinal Neoplasms
• Intestinal Neoplasms
• Liver Cancer
• Liver Neoplasms
• Malignant Carcinoid Syndrome
• Nausea
• Nausea and Vomiting
• Neuroendocrine Tumors
• Pancreatic Cancer
• Pancreatic Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer
• Small Intestine Cancer
• Stomach Neoplasms
• Vomiting

Intervention

Drug:
• palonosetron hydrochloride
Given IV

Other:
• placebo
Given IV

Locations

Country	Name	City	State
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Bismarck Cancer Center	Bismarck	North Dakota
United States	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania
United States	CCOP - Duluth	Duluth	Minnesota
United States	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota
United States	Miller - Dwan Medical Center	Duluth	Minnesota
United States	Elkhart Clinic, LLC	Elkhart	Indiana
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana
United States	Fergus Falls Medical Group, PA	Fergus Falls	Minnesota
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Big Sky Oncology	Great Falls	Montana
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Northern Montana Hospital	Havre	Montana
United States	St. Peter's Hospital	Helena	Montana
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Howard Community Hospital	Kokomo	Indiana
United States	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana
United States	Saint Joseph Regional Medical Center	Mishawaka	Indiana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois
United States	Michiana Hematology Oncology PC - Niles	Niles	Michigan
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	South Bend Clinic	South Bend	Indiana
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Door County Cancer Center at Door County Memorial Hospital	Sturgeon Bay	Wisconsin
United States	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin
United States	Michiana Hematology Oncology PC - La Porte	Westville	Indiana
United States	Wesley Medical Center	Wichita	Kansas
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response (no Episodes of Nausea or Vomiting)		Up to 2 years
Secondary	Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking = 3 Prochlorperazine or Haloperidol Tablets Per Day		Up to 2 years
Secondary	Proportion of Patients Reporting Treatment Failure		Up to 2 years
Secondary	Tolerability and Adverse Events as Assessed by NCI CTC v 3.0		Up to 2 years
Secondary	Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm		Up to 2 years