Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
Condition: 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
MeSH terms: Pancreatic Neoplasms; Stomach Neoplasms; Carcinoid Tumor; Anus Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Intestinal Neoplasms; Nausea; Vomiting
Intervention: palonosetron hydrochloride; placebo
Intervention description: Given IV; Given IV
Intervention MeSH terms: Palonosetron
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.
    

Eligibility 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