Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery

NCT ID: NCT00004895

Last Updated: 2012-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2002-10-31

Brief Summary

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RATIONALE: Palliative therapy with octreotide may help patients who have bowel obstruction that cannot be removed by surgery to live longer and more comfortably.

PURPOSE: Phase II trial to study the effectiveness of octreotide as palliative therapy in treating patients who have cancer-related bowel obstruction that cannot be removed by surgery.

Detailed Description

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OBJECTIVES:

* Determine the effectiveness of octreotide in the palliation of bowel obstruction secondary to cancer.
* Characterize the dose and tolerability of octreotide in this patient population.

OUTLINE: Patients receive octreotide subcutaneously or IV over 24 hours on days 2-5.

Patients who respond well to study may continue octreotide for palliative effects.

PROJECTED ACCRUAL: A total of 9-25 patients will be accrued for this study over 9 months.

Conditions

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Colorectal Cancer Constipation, Impaction, and Bowel Obstruction Extrahepatic Bile Duct Cancer Gastric Cancer Gastrointestinal Stromal Tumor Nausea and Vomiting Ovarian Cancer Pancreatic Cancer Peritoneal Cavity Cancer Small Intestine Cancer

Study Design

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Primary Study Purpose

SUPPORTIVE_CARE

Interventions

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octreotide acetate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Inoperable bowel obstruction secondary to cancer OR
* Metastatic or primary abdominal cancer
* Patient presents with vomiting
* Percutaneous gastrostomy tube allowed

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-4

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No documented hypersensitivity to octreotide
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior chemotherapy allowed

Endocrine therapy:

* Concurrent steroids allowed

Radiotherapy:

* Prior radiotherapy allowed

Surgery:

* Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Cameron Muir, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

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Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NU-97X1

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1685

Identifier Type: -

Identifier Source: secondary_id

NU 97X1

Identifier Type: -

Identifier Source: org_study_id

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