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

This study has been completed.

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   

Drug Information available for:   Octreotide    Octreotide acetate   

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
National Cancer Institute (NCI)

Investigators
Study Chair:     J. Cameron Muir, MD     Robert H. Lurie Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067573, NU-97X1, NCI-G00-1685
First Received:   March 7, 2000
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00004895
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:
Vomiting
Signs and Symptoms, Digestive
Gonadal Disorders
Leiomyosarcoma
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Octreotide
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Rectal Diseases
Genital Diseases, Female
Intestinal Obstruction
Duodenal Neoplasms
Signs and Symptoms
Stomach Diseases
Ileal Neoplasms
Biliary Tract Diseases
Stomach Neoplasms
Nausea
Rectal cancer
Lymphoma
Duodenal Diseases
Endocrine Gland Neoplasms
Bile duct cancer, extrahepatic
Jejunal Neoplasms
Ovarian cancer
Biliary Tract Neoplasms
Ovarian Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Jejunal Diseases
Therapeutic Uses
Gastrointestinal Agents
Ileal Diseases
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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