Advanced Well-differentiated Pancreatic Neuroendocrine TumorPhase 2NCT01845675
Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
A Phase 2 study testing temozolomide or dacarbazine-based chemotherapy, endostatin in people with Advanced Well-differentiated Pancreatic Neuroendocrine Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
- What is being tested?
- temozolomide or dacarbazine-based chemotherapy, endostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to 31 Mar 2017
- 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
- 18 years of age and older
- ECOG ≤2
- Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor.
- Prior treatment with one-line chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine or endostatin within the past 6 months
- Disease progressed during or after last therapy
- Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
Show all 11Show fewer
- Disease progressed within the past 12 months。
- Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated.
- Adequate bone marrow, liver and renal function
- Life expectancy 3 months or more
- Patient informed consent。
Who cannot join
- Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor.
- 2 or more lines of prior chemotherapy。
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Uncontrolled infectious disease。
- Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
- Uncontrolled brain or leptomeningeal metastases
- Patients with known hypersensitivity to temozolomide or endostatin。
- Patient could not take tablets。
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Medical Oncology, Peking Union Medical College Hospital
Beijing, 100730
About this study
Official title: Temozolomide or Dacarbazine-based Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor
- Being tested
- temozolomide or dacarbazine-based chemotherapy, endostatin
- Keywords
- temozolomide, endostatin, advanced, well-differentiated, pancreatic neuroendocrine tumor
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomide or dacarbazine-based chemotherapy, endostatinDrug
| Study group | Role | What they receive |
|---|---|---|
| temozolomide or dacarbazine-based chemotherapy, endostatin | Experimental | Endostatin 15mg/d，IV infusion, d1-d14 Temozolomide 150-200mg/m2/d，p.o., d1-d7 or dacarbazine 250mg/m2/d, IV infusion, d1-5, 5-FU 500mg/m2/d, IV infusion d1-5 Repeat every 3 weeks. Receives: Drug: temozolomide or dacarbazine-based chemotherapy, endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: up to 12 months
Secondary outcomes (2)
progression free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
toxicities
Measured: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completion30 Nov 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Well-differentiated Pancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YueJuan Cheng, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845675
- Sponsor's protocol ID
- TEPNET
- Status last verified
- Apr 2017
- First submitted
- 29 Apr 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temozolomide or Dacarbazine-based Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
- ClinicalTrials.gov ID
- NCT01845675
- Acronym / sponsor ID
- TEPNET
- Keywords
- temozolomide, endostatin, advanced, well-differentiated, pancreatic neuroendocrine tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 3 May 2013 (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.
Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| temozolomide or dacarbazine-based chemotherapy, endostatin | Experimental | Drug: temozolomide or dacarbazine-based chemotherapy, endostatinEndostatin 15mg/d，IV infusion, d1-d14 Temozolomide 150-200mg/m2/d，p.o., d1-d7 or dacarbazine 250mg/m2/d, IV infusion, d1-5, 5-FU 500mg/m2/d, IV infusion d1-5 Repeat every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age and older
- ECOG ≤2
- Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor.
- Prior treatment with one-line chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine or endostatin within the past 6 months
- Disease progressed during or after last therapy
Key exclusion criteria (8 listed)
- Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor.
- 2 or more lines of prior chemotherapy。
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Uncontrolled infectious disease。
- Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
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 |
|---|---|---|
| temozolomide or dacarbazine-based chemotherapy, endostatin | Drug | temozolomide or dacarbazine-based chemotherapy, endostatin |
Primary outcome
overall response rate
Time frame: up to 12 months
2 secondary outcomes
progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
toxicities
Time frame: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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 13 Apr 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 temozolomide or dacarbazine-based chemotherapy, endostatin in people with Advanced Well-differentiated Pancreatic Neuroendocrine Tumor, run by Peking Union Medical College Hospital at 1 site in China.
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 8 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 13 Apr 2017. 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 China. 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?
overall response rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
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 13 Apr 2017.