Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
Conditions
Keywords
temozolomide, endostatin, advanced, well-differentiated, pancreatic neuroendocrine tumor
Brief summary
Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor
Interventions
DRUGtemozolomide or dacarbazine-based chemotherapy, endostatin
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age and older 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
1. Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor. 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。
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | up to 12 months |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed