Colorectal CancerPhase 2NCT00004895
Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
A Phase 2 study testing octreotide acetate in people with Colorectal Cancer and Constipation, Impaction, and Bowel Obstruction, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer
- What is being tested?
- octreotide acetate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Oct 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
About this study
Official title: Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study
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.
Read the 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.
- Conditions
- Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer, Gastric Cancer, Gastrointestinal Stromal Tumor, Nausea and Vomiting
- Being tested
- octreotide acetate
- 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
- Medical subject headings
- Colorectal Neoplasms, Constipation, Intestinal Obstruction, Bile Duct Neoplasms, Stomach Neoplasms, Gastrointestinal Stromal Tumors, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octreotide acetateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2003 (estimated)
- Study startOct 1999
- Primary completionOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- J. Cameron Muir, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004895
- Sponsor's protocol ID
- NU 97X1
- Other IDs
- NU-97X1, NCI-G00-1685
- Status last verified
- May 2012
- First submitted
- 7 Mar 2000
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study
- ClinicalTrials.gov ID
- NCT00004895
- Acronym / sponsor ID
- NU 97X1
- Conditions
- Colorectal Cancer, Constipation, Impaction, and Bowel Obstruction, Extrahepatic Bile Duct Cancer, Gastric Cancer, Gastrointestinal Stromal Tumor, Nausea and Vomiting
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 9 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| octreotide acetate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Cameron Muir, MD study chair
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing octreotide acetate in people with Colorectal Cancer and Constipation, Impaction, and Bowel Obstruction, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.