A Phase 2 interventional study of palonosetron hydrochloride and placebo in Anal Cancer, Carcinoma of the Appendix and Colorectal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Terminated at 69 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Supportive care
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:
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.
Patients complete nausea and vomiting questionnaires and diaries at baseline and daily during radiotherapy. Patients also complete symptom experience diaries weekly during radiotherapy.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 7 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 7 days since prior agents known to have significant effects on emesis, including the following:
Patients receive palonosetron hydrochloride IV on day 1.
Drug: palonosetron hydrochloride
Patients receive palonosetron hydrochloride IV on days 1 and 4.
Drug: palonosetron hydrochloride
Patients receive placebo IV on day 1.
Other: placebo
Patients receive placebo IV on days 1 and 4.
Other: placebo
Given IV
Given IV
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
| Milestone | Arm I | Arm II | Arm III | Arm IV |
|---|---|---|---|---|
| Started | 2 | 1 | 3 | 1 |
| Completed | 2 | 1 | 3 | 1 |
| Not completed | 0 | 0 | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | — | — |
| Arm II | — | — | — |
| Arm III | — | — | — |
| Arm IV | — | — | — |
Not enough patients were accrued. In order to avoid identification of patients, no results will be entered.
| Age, Continuous | Arm I | Arm II | Arm III | Arm IV | Total |
|---|
| Sex: Female, Male | Arm I | Arm II | Arm III | Arm IV | Total |
|---|---|---|---|---|---|
| Female | — | — | — | — | — |
| Male | — | — | — | — | — |
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology