This phase II trial studies how well octreotide, dexamethasone, and metoclopramide work in treating patients with malignant bowel obstruction that cannot be treated by surgery (inoperable). Giving octreotide, dexamethasone, and metoclopramide together may help patients resume an oral diet, move bowels without pain, and remove the need to be fed intravenously.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04027348.
PRIMARY OBJECTIVE:
I. To identify role of palliative medical management of inoperable malignant bowel obstruction (MBO) with octreotide, dexamethasone sodium phosphate (dexamethasone) and metoclopramide given together as triple therapy.
SECONDARY OBJECTIVES:
I. To examine the time to de-obstruction.
II. To assess how well patients with MBO tolerate the combination therapy regimens.
III. To measure the overall survival of patients who receive the triple therapy at 3 and 6 months post obstruction or de-obstruction.
OUTLINE:
Patients receive octreotide intravenously (IV) three times daily (TID), dexamethasone IV twice daily (BID), and metoclopramide IV every 6 hours (Q6H) for 7 days in the absence of disease progression or unacceptable toxicity. Patients with de-obstruction within the first 7 days may receive octreotide IV TID, dexamethasone orally (PO) BID, and metoclopramide PO Q6H for another 7 days from time of de-obstruction or discharge. Patients then receive metoclopramide PO Q6H and dexamethasone PO BID for 3 more days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, then at 3 and 6 months from the time of discharge.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorAmy Allen Case
