Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patie… (NCT00903396) | Clinical Trial Compass
TerminatedPhase 2
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
Stopped: Slow accrual
United States7 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 day…
What they're measuring
1
Complete Response (no Episodes of Nausea or Vomiting)