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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:
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

March 7, 2000
May 31, 2012
October 1999
October 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004895 on ClinicalTrials.gov Archive Site
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Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study

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.

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.

Interventional
Phase 2
Primary Purpose: Supportive Care
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2002
October 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004895
NU 97X1, NU-97X1, NCI-G00-1685
Yes
Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: J. Cameron Muir, MD Robert H. Lurie Cancer Center
Northwestern University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP