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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

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

NCT ID

NCT00004895

First Posted

March 7, 2000

Last Updated

May 31, 2012

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

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

Eligibility Criteria

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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