Palliative Management of Inoperable Malignant Bowel Obstruction

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT04027348

Collaborator

(none)

Enrollment

Location

Arm

26.3

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Bowel Obstruction	Drug: Dexamethasone Drug: Metoclopramide Drug: Octreotide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center

Actual Study Start Date :

Jun 26, 2019

Actual Primary Completion Date :

Sep 3, 2021

Actual Study Completion Date :

Sep 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (octreotide, dexamethasone, metoclopramide) IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.	Drug: Dexamethasone Given IV Drug: Metoclopramide Given IV Drug: Octreotide Given IV

Arm

Intervention/Treatment

Experimental: Treatment (octreotide, dexamethasone, metoclopramide)

IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.

Drug: Dexamethasone

Given IV

Drug: Metoclopramide

Given IV

Drug: Octreotide

Given IV

Outcome Measures

Primary Outcome Measures

Proportion of patients with Obstruction Clearance [Within 7 days of starting protocol therapy]
Clearing of malignant bowel obstruction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263

Sponsors and Collaborators

Roswell Park Cancer Institute

Investigators

Principal Investigator: Amy Case, MD, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roswell Park Cancer Institute

ClinicalTrials.gov Identifier:

NCT04027348

Other Study ID Numbers:

I 74018

First Posted:

Jul 22, 2019

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Roswell Park Cancer Institute

bowel obstruction

Additional relevant MeSH terms:

Intestinal Obstruction

Dexamethasone

Octreotide

Metoclopramide

Study Results

No Results Posted as of May 18, 2022