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

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
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	Phase II

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Constipation 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

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000067573, NU-97X1, NCI-G00-1685
Study First Received:	March 7, 2000
Last Updated:	May 9, 2009
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:

Signs and Symptoms, Digestive
Pancreatic Neoplasms
Colonic Diseases
Octreotide
Urogenital Neoplasms
Rectal Diseases
Ileal Diseases
Intestinal Obstruction
Duodenal Neoplasms
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Digestive System Neoplasms
Antineoplastic Agents, Hormonal

Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms
Bile Duct Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Bile Duct Neoplasms
Vomiting
Gastrointestinal Diseases
Gonadal Disorders
Antineoplastic Agents
Ovarian Diseases
Genital Diseases, Female
Signs and Symptoms
Stomach Diseases

ClinicalTrials.gov processed this record on July 02, 2009