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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004895
• Other study ID #: NU 97X1
• Secondary ID: NU-97X1NCI-G00-1
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: May 31, 2012
• Start date: October 1999
• Est. completion date: October 2002

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Colorectal Cancer
• Constipation
• Constipation, Impaction, and Bowel Obstruction
• Extrahepatic Bile Duct Cancer
• Gastric Cancer
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Intestinal Obstruction
• Nausea and Vomiting
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms
• Small Intestine Cancer
• Stomach Neoplasms

Intervention

Drug:
• octreotide acetate

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,