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

Phase 2

Terminated

• Conditions: 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
• Interventions: Drug: palonosetron hydrochloride; Other: placebo

• Registration Number: NCT00903396
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

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.

Study Timeline

• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-15
• Study First Posted: 2009-05-18
• Study Start: 2009-09
• Primary Completion: 2011-01
• Study Completion: 2013-05
• Results First Submitted: 2016-12-07
• Results First Submitted QC: 2016-12-07
• Results First Posted: 2017-02-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-20
• Last Update Posted: 2017-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	palonosetron hydrochloride	Patients receive palonosetron hydrochloride IV on day 1.
Arm II	palonosetron hydrochloride	Patients receive palonosetron hydrochloride IV on days 1 and 4.
Arm III	placebo	Patients receive placebo IV on day 1.
Arm IV	placebo	Patients receive placebo IV on days 1 and 4.

Primary Outcome Measures

Name	Time	Method
Complete Response (no Episodes of Nausea or Vomiting)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
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
Proportion of Patients Reporting Treatment Failure	Up to 2 years
Tolerability and Adverse Events as Assessed by NCI CTC v 3.0	Up to 2 years
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm	Up to 2 years

Trial Locations

Locations (67)

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus; 🇺🇸 Moline, Illinois, United States

Elkhart Clinic, LLC; 🇺🇸 Elkhart, Indiana, United States

Michiana Hematology-Oncology, PC - Elkhart; 🇺🇸 Elkhart, Indiana, United States

Elkhart General Hospital; 🇺🇸 Elkhart, Indiana, United States

Howard Community Hospital; 🇺🇸 Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services; 🇺🇸 La Porte, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend; 🇺🇸 Mishawaka, Indiana, United States

Saint Joseph Regional Medical Center; 🇺🇸 Mishawaka, Indiana, United States

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