Malignant Bowel ObstructionPhase 2NCT04027348

Palliative Management of Inoperable Malignant Bowel Obstruction

A Phase 2 study testing Dexamethasone, Metoclopramide and Octreotide in people with Malignant Bowel Obstruction, run by Roswell Park Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Bowel Obstruction
What is being tested?: Dexamethasone, Metoclopramide and Octreotide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 26 Jun 2019to 3 Sep 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

Lack of decision making capacity/delirium.
Pregnant or nursing female participants.
Actively suicidal patients.
Acute cholecystitis

Trial locations and contacts

1 site in 1 country.

United States1 site

Roswell Park Cancer Institute
Buffalo, New York, 14263

Other trials in United States

About this study

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

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

Conditions: Malignant Bowel Obstruction
Being tested: Dexamethasone, Metoclopramide, Octreotide
Keywords: bowel obstruction
Medical subject headings: Intestinal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Given IV
MetoclopramideDrug
Given IV
OctreotideDrug
Given IV

Study groups in NCT04027348
Study group	Role	What they receive
Treatment (octreotide, dexamethasone, metoclopramide)	Experimental	IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h. Receives: Drug: Dexamethasone; Drug: Metoclopramide; Drug: Octreotide

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 7 days of starting protocol therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20193 Sep 2021

First posted22 Jul 2019
Study start26 Jun 2019
Primary completion3 Sep 2021
Study completion3 Sep 2021

Why it stopped: low accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Malignant Bowel ObstructionStudies of the same condition, open and under way.
More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04027348
Sponsor's protocol ID: I 74018
Status last verified: Sep 2022
First submitted: 18 Jul 2019
Last updated: 29 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
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All Malignant Bowel Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Palliative Management of Inoperable Malignant Bowel Obstruction: A Prospective, Open Label, Phase-2 Study at an NCI Comprehensive Cancer Center
ClinicalTrials.gov ID: NCT04027348
Acronym / sponsor ID: I 74018
Conditions: Malignant Bowel Obstruction
Keywords: bowel obstruction
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: low accrual
Enrolment: 15 participants (actual)
Lead sponsor: Roswell Park Cancer InstituteUniversity, hospital or other
Study start: 26 Jun 2019 (actual)
Primary completion: 3 Sep 2021 (actual)
Study completion: 3 Sep 2021 (actual)
First posted: 22 Jul 2019 (actual)
Results: Posted 29 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneGiven IV	Drug	Treatment (octreotide, dexamethasone, metoclopramide)
MetoclopramideGiven IV	Drug	Treatment (octreotide, dexamethasone, metoclopramide)
OctreotideGiven IV	Drug	Treatment (octreotide, dexamethasone, metoclopramide)

Primary outcome

Proportion of Patients With Obstruction Clearance
Time frame: Within 7 days of starting protocol therapy
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.

Results and safety

Results posted to the registry on 29 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Octreotide, Dexamethasone, Metoclopramide)	15	13

Primary outcome: Proportion of Patients With Obstruction Clearance

Time frame: Within 7 days of starting protocol therapy. Count of participants. Unit: Participants

Measure	Treatment (Octreotide, Dexamethasone, Metoclopramide) n = 13
Value	10

Population analysed: 2 Patients did not complete treatment and were not evaluated for de-obstruction (due to AEs).

Adverse events

Time frame: From start of treatment up to 30-days after treatment, where treatment was an average of 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Octreotide, Dexamethasone, Metoclopramide)	6 of 15 (40%)	11 of 15 (73.3%)	13 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Malignant Bowel Obstruction

Not yet recruitingObservational study
Lidocaine Infusions for Pain in Patients With Malignant Bowel Obstruction
Malignant Bowel Obstruction, Cancer Pain
Not yet recruiting
Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery
Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Active, not recruiting
Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents
Pancreatic Cancer Non-resectable, Bile Duct Cancer
Not yet recruiting
Multimodal Prehabilitation for Tumor-Related Bowel Obstruction
Malignant Tumor, Prehabilitation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Case, MD principal investigator

Roswell Park Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Metoclopramide and Octreotide in people with Malignant Bowel Obstruction, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Obstruction Clearance (time frame: Within 7 days of starting protocol therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04027348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.