Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
NCT ID: NCT01845675
Last Updated: 2017-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2013-04-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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temozolomide or dacarbazine-based chemotherapy, endostatin
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.
temozolomide or dacarbazine-based chemotherapy, endostatin
Interventions
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temozolomide or dacarbazine-based chemotherapy, endostatin
Eligibility Criteria
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Inclusion Criteria
2. ECOG ≤2
3. Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor.
4. 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
5. Disease progressed during or after last therapy
6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
7. Disease progressed within the past 12 months。
8. Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated.
9. Adequate bone marrow, liver and renal function
10. Life expectancy 3 months or more
11. Patient informed consent。
Exclusion Criteria
2. 2 or more lines of prior chemotherapy。
3. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
4. Uncontrolled infectious disease。
5. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
6. Uncontrolled brain or leptomeningeal metastases
7. Patients with known hypersensitivity to temozolomide or endostatin。
8. Patient could not take tablets。
18 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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YueJuan Cheng
attending medical oncologist
Locations
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Division of Medical Oncology, Peking Union Medical College Hospital
Beijing, , China
Countries
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Other Identifiers
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TEPNET
Identifier Type: -
Identifier Source: org_study_id
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