Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Phase 2

Completed

• Conditions: Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
• Interventions: Drug: temozolomide or dacarbazine-based chemotherapy, endostatin

• Registration Number: NCT01845675
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-03
• Primary Completion: 2016-11-30
• Study Completion: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
temozolomide or dacarbazine-based chemotherapy, endostatin	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.

Primary Outcome Measures

Name	Time	Method
overall response rate	up to 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Medical Oncology, Peking Union Medical College Hospital; 🇨🇳 Beijing, China