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

Tracking Information

First Received Date ^ICMJE

March 7, 2000

Last Updated Date

May 9, 2009

Start Date ^ICMJE

October 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004895 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: octreotide acetate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004895

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067573, NU-97X1, NCI-G00-1685

Study Sponsor ^ICMJE

Robert H. Lurie Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

J. Cameron Muir, MD

Robert H. Lurie Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP