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

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Palonosetron

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