Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

• Status: Completed
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Dacarbazine; Endostatins; Temozolomide

Criteria

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。