Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Advanced Well-differentiated Pancreatic Neuroendocrine Tumor

Treatments: Drug: temozolomide or dacarbazine-based chemotherapy, endostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01845675

TEPNET

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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。

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

temozolomide or dacarbazine-based chemotherapy, endostatin

Experimental group

Description:

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.

Treatment:

Drug: temozolomide or dacarbazine-based chemotherapy, endostatin