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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

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

Condition or disease Intervention/treatment Phase
Advanced Well-differentiated Pancreatic Neuroendocrine Tumor Drug: temozolomide or dacarbazine-based chemotherapy, endostatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Temozolomide or Dacarbazine-based Chemotherapy Plus Endostatin in Advanced Pancreatic Neuroendocrine Tumor
Study Start Date : April 2013
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : March 31, 2017


Arm Intervention/treatment
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.
Drug: temozolomide or dacarbazine-based chemotherapy, endostatin



Primary Outcome Measures :
  1. overall response rate [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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。

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845675


Locations
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China
Division of Medical Oncology, Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital

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Responsible Party: YueJuan Cheng, attending medical oncologist, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01845675     History of Changes
Other Study ID Numbers: TEPNET
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YueJuan Cheng, Peking Union Medical College Hospital:
temozolomide
endostatin
advanced
well-differentiated
pancreatic neuroendocrine tumor
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Adenoma, Islet Cell
Adenoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Temozolomide
Endostatins
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors