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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| 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 Malignant Tumor of Peritoneum Small Intestine Cancer |
Drug: octreotide acetate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study |
| Study Start Date: | October 1999 |
| Study Completion Date: | October 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Study Chair: | J. Cameron Muir, MD | Robert H. Lurie Cancer Center |
More Information
| Responsible Party: | Cameron Muir, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00004895 History of Changes |
| Other Study ID Numbers: | NU 97X1, NU-97X1, NCI-G00-1685 |
| Study First Received: | March 7, 2000 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Federal Government |
|
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 |
|
Neoplasms Colorectal Neoplasms Constipation Intestinal Obstruction Stomach Neoplasms Nausea Vomiting Ovarian Neoplasms Pancreatic Neoplasms Peritoneal Neoplasms Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Bile Duct Neoplasms Gastrointestinal Stromal Tumors |
Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Signs and Symptoms, Digestive Signs and Symptoms Stomach Diseases Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases |