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Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01845675
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
YueJuan Cheng, Peking Union Medical College Hospital

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 3, 2013
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
overall response rate [ Time Frame: up to 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
Progression free survival [ Time Frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]
Change History Complete list of historical versions of study NCT01845675 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2016)
  • 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 ]
  • toxicities [ Time Frame: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2013)
overall survival [ Time Frame: From date of treatment until the date of death, assessed up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
Official Title  ICMJE Temozolomide or Dacarbazine-based Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
Brief Summary Temozolomide or dacarbazine-based chemotherapy combined with endostatin have efficacy in well-differentiated pancreatic neuroendocrine tumor
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
Intervention  ICMJE Drug: temozolomide or dacarbazine-based chemotherapy, endostatin
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: temozolomide or dacarbazine-based chemotherapy, endostatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2013)
10
Actual Study Completion Date  ICMJE March 31, 2017
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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。
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01845675
Other Study ID Numbers  ICMJE TEPNET
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party YueJuan Cheng, Peking Union Medical College Hospital
Study Sponsor  ICMJE Peking Union Medical College Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking Union Medical College Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP