Status:

COMPLETED

Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

Lead Sponsor:

Peking Union Medical College Hospital

Conditions:

Advanced Well-differentiated Pancreatic Neuroendocrine Tumor

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 18 years of age and older
  • ECOG ≤2
  • Pathologically confirmed locally advanced or metastatic well-differentiated pancreatic neuroendocrine tumor.
  • 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
  • Disease progressed during or after last therapy
  • Minimum of 4 weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
  • Disease progressed within the past 12 months。
  • Patients must have at least one measurable site of disease according to RECIST1.1 criteria that has not been previously irradiated.
  • Adequate bone marrow, liver and renal function
  • Life expectancy 3 months or more
  • Patient informed consent。

Exclusion

  • Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine tumor.
  • 2 or more lines of prior chemotherapy。
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Uncontrolled infectious disease。
  • Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
  • Uncontrolled brain or leptomeningeal metastases
  • Patients with known hypersensitivity to temozolomide or endostatin。
  • Patient could not take tablets。

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2017

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT01845675

Start Date

April 1 2013

End Date

March 31 2017

Last Update

April 13 2017

Active Locations (1)

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Division of Medical Oncology, Peking Union Medical College Hospital

Beijing, China, 100730