Neuroendocrine TumorsPhase 2NCT00137774
Bevacizumab in Combination With Temozolomide in Patients With Neuroendocrine Tumors
A Phase 2 study testing Bevacizumab and Temozolomide in people with Neuroendocrine Tumors, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Bevacizumab and Temozolomide
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2004to Dec 2012
- 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
Who may be able to join
- Histologically documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
- Measurable disease > 1cm by spiral computed tomography (CT) or > 2cm by other radiographic technique
- ECOG performance status of 0-2
- Life expectancy of > 12 weeks
- Prior treatment with chemotherapy is allowed
- Total bilirubin < 2.0mg/dl
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- AST < 5x upper limit of normal (ULN)
- Serum creatinine < 2.0mg/dl
- Absolute neutrophil count > 1,000/mm3
- Platelets > 100,000/mm3
- International Normalized Ratio (INR) < 1.5
Who cannot join
- Prior treatment with temozolomide, decarbazine or bevacizumab
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Clinically significant cardiovascular disease
- Major surgery, open biopsy, or significant traumatic injury within 28 days
- Pregnant or breast-feeding women
- Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medication
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- Serious, nonhealing wound, ulcer or bone fracture
- Evidence of bleeding diathesis or coagulopathy
- History of other disease or metabolic dysfunction
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Insitute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.
Read the detailed description
Patients will receive temozolomide orally once daily for one week, followed by a one-week rest period. This one-week on/one week off schedule will continue for the duration of treatment unless significant side effects develop.
Bevacizumab will be administered intravenously every other week. After eight weeks (two cycles), a CT scan will be performed to see how treatment affected tumor growth.
Bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help prevent infection.
Blood tests will be done every other week to evaluate any side effects.
Once the study has been completed, a physical exam, vital signs, blood tests, and CT scan will be performed.
Patients will remain on the study as long as they continue to receive benefit from the treatment and there are no serious side effects.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Bevacizumab, Temozolomide
- Keywords
- Metastatic Neuroendocrine Tumor, Advanced Neuroendocrine tumor, Bevacizumab, Temozolomide
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Given intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects.
TemozolomideDrug
Given once daily for one week followed by a one week rest period. This one-week on/one-week off scheduled will be continued as long as there is no disease progression or serious side effects.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Measured: 2 years
Secondary outcomes (1)
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionJul 2005
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Schering-Plough
- Responsible party
- Principal investigator, Matthew H. Kulke, MD, Dana-Farber Cancer Institute
- Investigators
- Matthew H. Kulke, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137774
- Sponsor's protocol ID
- 04-272
- Status last verified
- Apr 2013
- First submitted
- 26 Aug 2005
- Last updated
- 9 Apr 2013
- Results posted
- No
Publications
Chan JA, Stuart K, Earle CC, Clark JW, Bhargava P, Miksad R, Blaszkowsky L, Enzinger PC, Meyerhardt JA, Zheng H, Fuchs CS, Kulke MH. Prospective study of bevacizumab plus temozolomide in patients with advanced neuroendocrine tumors. J Clin Oncol. 2012 Aug 20;30(24):2963-8. doi: 10.1200/JCO.2011.40.3147. Epub 2012 Jul 9.
PubMed 22778320
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bevacizumab in Combination With Temozolomide in Patients With Advanced Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT00137774
- Acronym / sponsor ID
- 04-272
- Conditions
- Neuroendocrine Tumors
- Keywords
- Metastatic Neuroendocrine Tumor, Advanced Neuroendocrine tumor, Bevacizumab, Temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Schering-Plough
- Study start
- Nov 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Aug 2005 (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.
The purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.
Detailed description
Patients will receive temozolomide orally once daily for one week, followed by a one-week rest period. This one-week on/one week off schedule will continue for the duration of treatment unless significant side effects develop.
Bevacizumab will be administered intravenously every other week. After eight weeks (two cycles), a CT scan will be performed to see how treatment affected tumor growth.
Bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help prevent infection.
Blood tests will be done every other week to evaluate any side effects.
Once the study has been completed, a physical exam, vital signs, blood tests, and CT scan will be performed.
Patients will remain on the study as long as they continue to receive benefit from the treatment and there are no serious side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma
- Measurable disease > 1cm by spiral computed tomography (CT) or > 2cm by other radiographic technique
- ECOG performance status of 0-2
- Life expectancy of > 12 weeks
- Prior treatment with chemotherapy is allowed
Key exclusion criteria (9 listed)
- Prior treatment with temozolomide, decarbazine or bevacizumab
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Clinically significant cardiovascular disease
- Major surgery, open biopsy, or significant traumatic injury within 28 days
- Pregnant or breast-feeding women
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 |
|---|---|---|
| BevacizumabGiven intravenously every other week. Participants can continue to receive study drug as long as there is no disease progression or serious side effects. | Drug | – |
| TemozolomideGiven once daily for one week followed by a one week rest period. This one-week on/one-week off scheduled will be continued as long as there is no disease progression or serious side effects. | Drug | – |
Primary outcome
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors
Time frame: 2 years
1 secondary outcome
To assess the time to progression, progression free survival and safety of bevacizumab in combination with temozolomide in this patient population
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 9 Apr 2013.
- Results publication: PubMed 22778320Chan JA, Stuart K, Earle CC, Clark JW, Bhargava P, Miksad R, Blaszkowsky L, Enzinger PC, Meyerhardt JA, Zheng H, Fuchs CS, Kulke MH. Prospective study of bevacizumab plus temozolomide in patients with advanced neuroendocrine tumors. J Clin Oncol. 2012 Aug 20;30(24):2963-8. doi: 10.1200/JCO.2011.40.3147. Epub 2012 Jul 9.
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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.
Matthew H. Kulke, MD principal investigator
Dana-Farber Cancer Institute
3 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 Bevacizumab and Temozolomide in people with Neuroendocrine Tumors, run by Dana-Farber Cancer Institute at 3 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?
The sponsor lists 11 inclusion and 9 exclusion criteria. 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 9 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
To assess the response to bevacizumab in combination with temozolomide in patients with metastatic neuroendocrine tumors (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00137774, which also lists 1 linked publication.
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 9 Apr 2013.