Completed

NCT Number: NCT00004895

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

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.

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Key information

Conditions

Colorectal Cancer Adnexal Diseases Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Carcinoma, Ovarian Epithelial Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Constipation Constipation, Impaction, and Bowel Obstruction Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Extrahepatic Bile Duct Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumor Gastrointestinal Stromal Tumors Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Intestinal Obstruction Nausea Nausea and Vomiting Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Peritoneal Cavity Cancer Rectal Diseases Rectal Neoplasms Signs and Symptoms Signs and Symptoms, Digestive Small Intestine Cancer Stomach Diseases Stomach Neoplasms Urogenital Diseases Urogenital Neoplasms Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

octreotide acetate

Drug

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 1999
Primary completion: 2002
Study completion: 2002
First posted: May 9, 2003
Registry last updated: Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed