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Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study


Phase 2
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

J. Cameron Muir, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 97X1

NCT ID:

NCT00004895

Start Date:

October 1999

Completion Date:

October 2002

Related Keywords:

  • 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
  • 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
  • Colorectal Neoplasms
  • Constipation
  • Fecal Impaction
  • Intestinal Obstruction
  • Stomach Neoplasms
  • Nausea
  • Vomiting
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Bile Duct Neoplasms
  • Peritoneal Neoplasms
  • Gastrointestinal Stromal Tumors
  • Intestinal Neoplasms

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611