Palliative Management of Inoperable Malignant Bowel Obstruction

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

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

Conditions
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Malignant Bowel Obstruction

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Metoclopramide
* Drug: Octreotide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel obstruction