Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
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|ClinicalTrials.gov Identifier: NCT00903396|
Recruitment Status : Terminated (Slow accrual)
First Posted : May 18, 2009
Results First Posted : February 1, 2017
Last Update Posted : November 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|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 Other: placebo||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting|
|Actual Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||May 2013|
Experimental: Arm I
Patients receive palonosetron hydrochloride IV on day 1.
Drug: palonosetron hydrochloride
Experimental: Arm II
Patients receive palonosetron hydrochloride IV on days 1 and 4.
Drug: palonosetron hydrochloride
Placebo Comparator: Arm III
Patients receive placebo IV on day 1.
Placebo Comparator: Arm IV
Patients receive placebo IV on days 1 and 4.
- Complete Response (no Episodes of Nausea or Vomiting) [ Time Frame: Up to 2 years ]
- 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 [ Time Frame: Up to 2 years ]
- Proportion of Patients Reporting Treatment Failure [ Time Frame: Up to 2 years ]
- Tolerability and Adverse Events as Assessed by NCI CTC v 3.0 [ Time Frame: Up to 2 years ]
- Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm [ Time Frame: Up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903396
|Study Chair:||Michele Yvette Halyard, MD||Mayo Clinic|