Status:
TERMINATED
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anal Cancer
Carcinoma of the Appendix
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 dosin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00903396
Start Date
September 1 2009
End Date
May 1 2013
Last Update
November 24 2017
Active Locations (69)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
3
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States, 61265
4
Moline, Illinois, United States, 61265