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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00903396
First received: May 15, 2009
Last updated: April 23, 2011
Last verified: March 2011

May 15, 2009
April 23, 2011
September 2009
August 2011   (final data collection date for primary outcome measure)
Complete response (no episodes of nausea or vomiting) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00903396 on ClinicalTrials.gov Archive Site
  • 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 [ Designated as safety issue: No ]
  • Proportion of patients reporting treatment failure [ Designated as safety issue: No ]
  • Tolerability and adverse events as assessed by NCI CTC v 3.0 [ Designated as safety issue: Yes ]
  • Average level of nausea reported and the proportion of patients experiencing a complete response independent of treatment arm [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting

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.

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.

Interventional
Phase 2
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
  • 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
  • Drug: palonosetron hydrochloride
    Given IV
  • Other: placebo
    Given IV
  • Experimental: Arm I
    Patients receive palonosetron hydrochloride IV on day 1.
    Intervention: Drug: palonosetron hydrochloride
  • Experimental: Arm II
    Patients receive palonosetron hydrochloride IV on days 1 and 4.
    Intervention: Drug: palonosetron hydrochloride
  • Placebo Comparator: Arm III
    Patients receive placebo IV on day 1.
    Intervention: Other: placebo
  • Placebo Comparator: Arm IV
    Patients receive placebo IV on days 1 and 4.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
Not Provided
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00903396
CDR0000642449, NCCTG-N08C2
Not Provided
Not Provided
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Michele Yvette Halyard, MD Mayo Clinic
National Cancer Institute (NCI)
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP