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

Alliance for Clinical Trials in Oncology

Status and phase: Terminated; Phase 2

Conditions: Anal Cancer; Nausea and Vomiting; Extrahepatic Bile Duct Cancer; Carcinoma of the Appendix; Liver Cancer; Small Intestine Cancer; Gallbladder Cancer; Primary Peritoneal Cavity Cancer; Gastric Cancer; Gastrointestinal Carcinoid Tumor; Pancreatic Cancer; Colorectal Cancer

Treatments: Other: placebo; Drug: palonosetron hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00903396

NCI-2009-01109 (Registry Identifier)

NCCTG-N08C2

CDR0000642449 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 4 patient groups, including a placebo group

Arm I

Experimental group

Description:

Patients receive palonosetron hydrochloride IV on day 1.

Treatment:

Drug: palonosetron hydrochloride

Arm II

Experimental group

Description:

Patients receive palonosetron hydrochloride IV on days 1 and 4.

Treatment:

Drug: palonosetron hydrochloride

Arm III

Placebo Comparator group

Description:

Patients receive placebo IV on day 1.

Treatment:

Other: placebo

Arm IV

Placebo Comparator group

Description:

Patients receive placebo IV on days 1 and 4.

Treatment:

Other: placebo