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

Primary Purpose

Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
octreotide acetate
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
May 31, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004895
Brief Title
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

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
October 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
octreotide acetate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Cameron Muir, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States

12. IPD Sharing Statement

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

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