Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-01 @ 12:37 AM
Study NCT ID:
NCT00004895
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003248', 'term': 'Constipation'}, {'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D001650', 'term': 'Bile Duct Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'SUPPORTIVE_CARE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'dispFirstSubmitDate': '2011-02-16', 'completionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-31', 'studyFirstSubmitDate': '2000-03-07', 'dispFirstSubmitQcDate': '2011-02-16', 'studyFirstSubmitQcDate': '2003-05-08', 'dispFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'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'], 'conditions': ['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']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Palliative therapy with octreotide may help patients who have bowel obstruction that cannot be removed by surgery to live longer and more comfortably.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effectiveness of octreotide in the palliation of bowel obstruction secondary to cancer.\n* Characterize the dose and tolerability of octreotide in this patient population.\n\nOUTLINE: Patients receive octreotide subcutaneously or IV over 24 hours on days 2-5.\n\nPatients who respond well to study may continue octreotide for palliative effects.\n\nPROJECTED ACCRUAL: A total of 9-25 patients will be accrued for this study over 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Inoperable bowel obstruction secondary to cancer OR\n* Metastatic or primary abdominal cancer\n* Patient presents with vomiting\n* Percutaneous gastrostomy tube allowed\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* ECOG 0-4\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No documented hypersensitivity to octreotide\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Prior chemotherapy allowed\n\nEndocrine therapy:\n\n* Concurrent steroids allowed\n\nRadiotherapy:\n\n* Prior radiotherapy allowed\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00004895', 'briefTitle': 'Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study', 'orgStudyIdInfo': {'id': 'NU 97X1'}, 'secondaryIdInfos': [{'id': 'NU-97X1'}, {'id': 'NCI-G00-1685'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'octreotide acetate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'J. Cameron Muir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}