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Completed

NCT Number: NCT01845675

Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Division of Medical Oncology, Peking Union Medical College Hospital

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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。

Treatment and study plan

temozolomide or dacarbazine-based chemotherapy, endostatin

Drug

Primary outcomes

  1. overall response rate

    Time frame: up to 12 months

Secondary outcomes

  1. progression free survival

    Time frame: 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

  2. toxicities

    Time frame: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 3, 2013
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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