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

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00903396

Purpose

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.

Condition	Intervention	Phase
Anal Cancer Carcinoma of the Appendix Colorectal Cancer Extrahepatic Bile Duct Cancer Gallbladder Cancer Gastric Cancer Gastrointestinal Carcinoid Tumor Liver Cancer Nausea and Vomiting Pancreatic Cancer Primary Peritoneal Cavity Cancer Small Intestine Cancer	Drug: palonosetron hydrochloride Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
Official Title:	A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting

Resource links provided by NLM:

MedlinePlus related topics: Anal Cancer Cancer Carcinoid Tumors Colorectal Cancer Intestinal Cancer Liver Cancer Nausea and Vomiting Pancreatic Cancer Stomach Cancer

Drug Information available for: RS 25233-197 Palonosetron Hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete response (no episodes of nausea or vomiting) [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Designated as safety issue: No ]
Proportion of patients reporting treatment failure [ Designated as safety issue: No ]
Tolerability and adverse events as assessed by NCI CTC v 3.0 [ Designated as safety issue: Yes ]
Average level of nausea reported and the proportion of patients experiencing a complete response independent of treatment arm [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	September 2009
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive palonosetron hydrochloride IV on day 1.	Drug: palonosetron hydrochloride Given IV
Experimental: Arm II Patients receive palonosetron hydrochloride IV on days 1 and 4.	Drug: palonosetron hydrochloride Given IV
Placebo Comparator: Arm III Patients receive placebo IV on day 1.	Other: placebo Given IV
Placebo Comparator: Arm IV Patients receive placebo IV on days 1 and 4.	Other: placebo Given IV

Detailed 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903396

Show 69 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Michele Yvette Halyard, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00903396 History of Changes
Other Study ID Numbers:	CDR0000642449, NCCTG-N08C2
Study First Received:	May 15, 2009
Last Updated:	April 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
gastrointestinal carcinoid tumor
anal cancer
carcinoma of the appendix
colon cancer
rectal cancer
extrahepatic bile duct cancer

gallbladder cancer
gastric cancer
liver and intrahepatic biliary tract cancer
pancreatic cancer
small intestine cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:

Anus Neoplasms
Carcinoid Tumor
Carcinoma
Colorectal Neoplasms
Liver Neoplasms
Stomach Neoplasms
Nausea
Vomiting
Pancreatic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Peritoneal Neoplasms

Malignant Carcinoid Syndrome
Gastrointestinal Neoplasms
Intestinal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on February 09, 2012