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Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
This study has been completed.
First Received: March 7, 2000   Last Updated: October 18, 2008   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004895
  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
Cancer-Related Problem/Condition
Colorectal Cancer
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 II

MedlinePlus related topics: Cancer Colorectal Cancer Intestinal Cancer Nausea and Vomiting Ovarian Cancer Palliative Care Pancreatic Cancer Stomach Cancer Surgery
Drug Information available for: Octreotide acetate Octreotide
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care
Official Title: Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1999
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
Genders Eligible for Study:   Both
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
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
Robert H. Lurie Cancer Center
Investigators
Study Chair: J. Cameron Muir, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067573, NU-97X1, NCI-G00-1685
Study First Received: March 7, 2000
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00004895     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Signs and Symptoms, Digestive
Rectal Neoplasms
Pancreatic Neoplasms
Colonic Diseases
Octreotide
Urogenital Neoplasms
Rectal Diseases
Ileal Diseases
Duodenal Neoplasms
Intestinal Obstruction
Peritoneal Diseases
Ovarian Cancer
Endocrine Gland Neoplasms
Digestive System Neoplasms
Antineoplastic Agents, Hormonal
Genital Neoplasms, Female
Endocrine System Diseases
Bile Duct Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Stomach Cancer
Bile Duct Neoplasms
Vomiting
Gastrointestinal Diseases
Leiomyosarcoma
Gonadal Disorders
Ovarian Diseases
Bile Duct Cancer, Extrahepatic
Genital Diseases, Female
Signs and Symptoms

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Antineoplastic Agents
Gonadal Disorders
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Octreotide
Urogenital Neoplasms
Ovarian Diseases
Ileal Diseases
Rectal Diseases
Genital Diseases, Female
Duodenal Neoplasms
Intestinal Obstruction
Signs and Symptoms
Neoplasms by Site
Stomach Diseases
Ileal Neoplasms
Jejunal Diseases
Therapeutic Uses
Biliary Tract Diseases
Stomach Neoplasms
Peritoneal Diseases
Duodenal Diseases
Endocrine Gland Neoplasms
Jejunal Neoplasms
Biliary Tract Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009