Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Study Overview
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Brief Summary
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Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor

Official Title
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Temozolomide or Dacarbazine-based Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Conditions
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Advanced Well-differentiated Pancreatic Neuroendocrine Tumor

Intervention / Treatment
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* Drug: temozolomide or dacarbazine-based chemotherapy, endostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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。 Exclusion Criteria: 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。

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: temozolomide or dacarbazine-based chemotherapy, endostatin<br>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. | Drug: temozolomide or dacarbazine-based chemotherapy, endostatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 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 |  | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temozolomide, endostatin, advanced, well-differentiated, pancreatic neuroendocrine tumor