Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Advanced Well-differentiated Pancreatic Neuroendocrine Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845675
• Other study ID #: TEPNET
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2013
• Last updated: April 12, 2017
• Start date: April 2013
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 31, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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?

Related Conditions & MeSH terms

• Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
• Carcinoid Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• temozolomide or dacarbazine-based chemotherapy, endostatin

Locations

Country	Name	City	State
China	Division of Medical Oncology, Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		up to 12 months
Secondary	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
Secondary	toxicities		Number of participants with treatment-related adverse events as assessed by CTCAE v4.0