Palliative Management of Inoperable Malignant Bowel Obstruction

• Status: Recruiting
• Trial end date: 2023-03-07
• Target enrollment: 0
• Participant gender: All

Summary

To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Metoclopramide; Octreotide

Criteria

Inclusion Criteria:

• Age ≥ 18 years of age.

• Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy.

• Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission.

• Patient must have an inoperable MBO

• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure.

Exclusion Criteria:

• Evidence of complete bowel obstruction by imaging.

• Bacteremia/septicemia with a documented positive blood culture: If a blood culture comes back positive after study enrollment, patient will be excluded.

• Patients already taking a steroid equivalent to 8 mg of dexamethasone per day prior to study enrollment.

• Patients undergoing bowel surgery or stent placement for bowel obstruction.

• Those patients with MBO in setting of incarcerated hernia.

• Known history of QT prolongation syndrome or if QTc is > 450 msec in males or > 470 msec in females on baseline EKG within 2 weeks of enrollment.

• Lack of decision making capacity/delirium.

• Pregnant or nursing female participants.

• Actively suicidal patients.

• Acute cholecystitis