Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Palliative Management of Inoperable Malignant Bowel Obstruction

NCTNCT04027348 (opens ClinicalTrials.gov in a new tab)Other idI 74018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
15 participants (actual)
Sponsor
Roswell Park Cancer Institute · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
26 Jun 2019
Primary completion
3 Sept 2021
Completion
3 Sept 2021
First posted
22 Jul 2019
Last update posted
29 Nov 2022
Conditions
Malignant Bowel Obstruction

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 2

    Palliative Management of Inoperable Malignant Bowel Obstruction

    NCT04027348

    26 Jun 2019 to 3 Sept 2021

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • DexamethasoneDrug
  • MetoclopramideDrug
  • OctreotideDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of Patients With Obstruction Clearance

    Time frame · Within 7 days of starting protocol therapy

    Registry description

    The primary efficacy endpoint is the proportion of eligible patients whose malignant bowel obstruction clears (de-obstruction) within 7 days of starting the protocol therapy. Patients meeting de-obstruction criteria within 7 days will be deemed treatment successes. De-obstruction is defined as: * Effective introduction of oral intake (yes/no) * Distinguished from small volumes of oral fluid that may be allowed with unresolved MBO * Tolerating oral liquid diet (day 1 of de-obstruction) that is able to be progressively more solid (oral or enteral) * Cessation of vomiting or ability for NGT or venting G tube to remain clamped without vomiting Rate of de-obstruction is defined as: \- From the date of study enrollment to the first observation of de-obstruction.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Within 7 days of starting protocol therapy

Proportion of Patients With Obstruction Clearance

GroupValue (Participants)
Treatment (Octreotide, Dexamethasone, Metoclopramide)10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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. Dexamethasone: Given IV Metoclopramide: Given IV Octreotide: Given IV13 / 156 / 1511 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.