Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy

Summary

RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by previous radiation therapy to the abdomen and pelvis.

Timeline

Start

1999-06

Primary completion

2006-04

Completion

—

Outcome

Missed primary endpoint

paper nor the response rate within sequelae category or the quality of life measures differed significantly between the 3 arms of the study. PMID 16601430 ↗

paper Administration of PPS has not been associated with an improvement in the clinical course of radiation related morbidity of the gastrointestinal tract. PMID 16601430 ↗

Publications

• Results Pilepich MV, Paulus R, St Clair W, Brasacchio RA, Rostock R, Miller RC. Phase III study of pentosanpolysulfate (PPS) in treatment of gastrointestinal tract sequelae of radiotherapy. Am J Clin Oncol. 2006 Apr;29(2):132-7. doi: 10.1097/01.coc.0000203758.77490.fd.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pentosan Polysulfate Sodium	Small molecule	100 mg	Oral
Subject	Pentosan Polysulfate Sodium	Small molecule	200 mg	Oral

Indications