Clinical trial NCT00004895: Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
Official title: Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Keywords: stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I gastric cancer
stage II gastric cancer
stage III gastric cancer
stage IV gastric cancer
recurrent gastric cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
small intestine adenocarcinoma
small intestine lymphoma
small intestine leiomyosarcoma
localized extrahepatic bile duct cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
recurrent small intestine cancer
constipation, impaction, and bowel obstruction
peritoneal cavity cancer
nausea and vomiting
gastrointestinal stromal tumor
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-05-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center, Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: J. Cameron Muir, MD
role: STUDY_CHAIR
References: