Palliative Management of Inoperable Malignant Bowel Obstruction

NCT04027348 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: I 74018
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Bowel Obstruction

Keywords

bowel obstruction

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 7 days of starting protocol therapy

Study Arms (1)

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.

Drug: Dexamethasone; Drug: Metoclopramide; Drug: Octreotide

Interventions

Dexamethasone DRUG

Given IV

Treatment (octreotide, dexamethasone, metoclopramide)

Metoclopramide DRUG

Given IV

Treatment (octreotide, dexamethasone, metoclopramide)

Octreotide DRUG

Given IV

Treatment (octreotide, dexamethasone, metoclopramide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Intestinal Obstruction

Interventions

Dexamethasone; Metoclopramide; Octreotide

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kris Attwood
• Organization: Roswell Park Comprehensive Cancer Center

Kris.Attwood@roswellpark.org

716-845-2300

Study Officials

• Amy Case, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: June 26, 2019
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: November 29, 2022
• Results First Posted: November 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)