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

Northwestern University

Status and phase: Completed; Phase 2

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

Treatments: Drug: octreotide acetate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004895

NU 97X1

NU-97X1

NCI-G00-1685

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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