Gastrointestinal Carcinoid TumorPhase 2NCT00017199
PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
A Phase 2 study testing bortezomib in people with Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- What is being tested?
- bortezomib
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Apr 2001to May 2007
- 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:
- Histologically confirmed metastatic carcinoid tumor or islet cell tumor
- Well-differentiated neuroendocrine tumor OR
- Well-differentiated neuroendocrine carcinoma
- Measurable disease in at least 1 dimension
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- The following are considered nonmeasurable:
- Lesions in a previously irradiated area
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed
- Cystic lesions
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 6 months
Hematopoietic:
- Leukocyte count at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other:
- No other uncontrolled illness
- No ongoing active infection
- No psychiatric illness or social situation that would preclude study
- No history of allergic reaction to compounds of similar chemical or biologic composition to bortezomib
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy (interferon alfa)
Chemotherapy:
- No more than 1 prior systemic chemotherapy regimen (except hepatic artery chemoembolization)
- At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas)
- At least 12 weeks since prior hepatic artery chemoembolization (unless liver lesions are not indicator lesions)
- Stable dose long-acting octreotide therapy (Sandostatin LAR) within the past 3 months allowed
- Concurrent subcutaneous octreotide for breakthrough symptomatic relief allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational agents, commercial agents, or therapies
- No concurrent combination antiretroviral therapy for HIV-positive patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
About this study
Official title: Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic neuroendocrine tumors.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with bortezomib.
- Determine the toxicity of this drug in this patient population.
- Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 6 months.
- Conditions
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- Being tested
- bortezomib
- Keywords
- metastatic gastrointestinal carcinoid tumor, gastrinoma, insulinoma, somatostatinoma, glucagonoma
- Medical subject headings
- Adenoma, Islet Cell, Gastrinoma, Insulinoma, Somatostatinoma, Glucagonoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startApr 2001
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Carcinoid TumorStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Treatment
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Manisha H. Shah, MD, Study chair, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017199
- Sponsor's protocol ID
- CDR0000068660
- Other IDs
- OSU-00H0328, NCI-1856
- Status last verified
- May 2007
- First submitted
- 6 Jun 2001
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00017199
- Acronym / sponsor ID
- CDR0000068660
- Conditions
- Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
- Keywords
- metastatic gastrointestinal carcinoid tumor, gastrinoma, insulinoma, somatostatinoma, glucagonoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2001
- Study completion
- May 2007 (actual)
- First posted
- 16 Feb 2004 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic neuroendocrine tumors.
Detailed description
OBJECTIVES:
- Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with bortezomib.
- Determine the toxicity of this drug in this patient population.
- Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 6 months.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| bortezomib | 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 31 Jan 2013.
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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.
Manisha H. Shah, MD study chair
Ohio State University Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib in people with Gastrointestinal Carcinoid Tumor and Islet Cell Tumor, run by Ohio State University Comprehensive Cancer Center at 2 sites 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 31 Jan 2013.