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 Primary Peritoneal Cavity Cancer Small Intestine Cancer
Keywords: 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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

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.

Arms:
arm 1: Patients receive palonosetron hydrochloride IV on day 1. arm 2: Patients receive palonosetron hydrochloride IV on days 1 and 4. arm 3: Patients receive placebo IV on day 1. arm 4: Patients receive placebo IV on days 1 and 4.

Interventions: intervention 1: palonosetron hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol document: