Digestive System Diseases

All Conditions

Intestinal Obstruction

Intestinal Diseases

Gastrointestinal Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Cardiotonic Agents

Dexamethasone

Dexamethasone acetate

Metoclopramide

Octreotide

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

IV octreotide 300 mcg TID + IV dexamethasone 4 mg BID (first dose 9am and second at 2pm) + IV metoclopramide 10 mg q6h.

Amy Case, MD

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

Palliative Management of Inoperable Malignant Bowel Obstruction

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

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.

Roswell Park Cancer Institute

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 IV

Treatment (Octreotide, Dexamethasone, Metoclopramide)

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

KARNOFSKY PERFORMANCE STATUS SCALE

The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses.

The score ranges from 0 to 100.

Performance Status

Kris Attwood

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

Proportion of Patients With Obstruction Clearance

Overall Study

Spots Global Cancer Trial Database for Palliative Management of Inoperable Malignant Bowel Obstruction

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial