Back to resultsPalliative Management of Inoperable Malignant Bowel Obstruction
Primary Purpose
Malignant Bowel Obstruction
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Metoclopramide
Octreotide
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Bowel Obstruction focused on measuring bowel obstruction
Eligibility 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
Sites / Locations
- Roswell Park Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (octreotide, dexamethasone, metoclopramide)
Arm Description
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Outcomes
Primary Outcome Measures
Proportion of Patients With Obstruction Clearance
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04027348
First Posted
July 18, 2019
Last Updated
November 9, 2022
Sponsor
Roswell Park Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT04027348
Brief Title
Palliative Management of Inoperable Malignant Bowel Obstruction
Official Title
Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Bowel Obstruction
Keywords
bowel obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (octreotide, dexamethasone, metoclopramide)
Arm Type
Experimental
Arm Description
IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Octreotide
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Proportion of Patients With Obstruction Clearance
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.
Time Frame
Within 7 days of starting protocol therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Case, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Palliative Management of Inoperable Malignant Bowel Obstruction
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