NCT00004895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 9, 2003

Completed
Last Updated

June 6, 2012

Status Verified

May 1, 2012

Enrollment Period

3 years

First QC Date

March 7, 2000

Last Update Submit

May 31, 2012

Conditions

Colorectal CancerConstipation, Impaction, and Bowel ObstructionExtrahepatic Bile Duct CancerGastric CancerGastrointestinal Stromal TumorNausea and VomitingOvarian CancerPancreatic CancerPeritoneal Cavity CancerSmall Intestine Cancer

Keywords

stage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerstage I gastric cancerstage II gastric cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent pancreatic cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancersmall intestine adenocarcinomasmall intestine lymphomasmall intestine leiomyosarcomalocalized extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerconstipation, impaction, and bowel obstructionperitoneal cavity cancernausea and vomitinggastrointestinal stromal tumor

Interventions

octreotide acetateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsConstipationIntestinal ObstructionBile Duct NeoplasmsStomach NeoplasmsGastrointestinal Stromal TumorsNauseaVomitingOvarian NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesStomach DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • J. Cameron Muir, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

May 9, 2003

Study Start

October 1, 1999

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

June 6, 2012

Record last verified: 2012-05

Locations

US(1)