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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004895
First received: March 7, 2000
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
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 Drug: octreotide acetate Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Study Start Date: October 1999
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004895

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Study Chair: J. Cameron Muir, MD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004895     History of Changes
Other Study ID Numbers: NU 97X1
NU-97X1
NCI-G00-1685
Study First Received: March 7, 2000
Last Updated: May 31, 2012

Keywords provided by Northwestern University:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Constipation
Nausea
Vomiting
Gastrointestinal Stromal Tumors
Peritoneal Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Intestinal Neoplasms
Intestinal Obstruction
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 23, 2017