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Trial record 18 of 1294 for:    survival | Neuroendocrine Tumors

A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors (MetNet)

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ClinicalTrials.gov Identifier: NCT02279758
Recruitment Status : Unknown
Verified October 2014 by Instituto do Cancer do Estado de São Paulo.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Brief Summary:

Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence. The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may be an alternative treatment for this disease.

Eligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg every 12 hours, and each cycle will consist of 30 days. After 180 days of treatment the efficacy of metformin under the control of disease progression will be evaluated. As a secondary outcome the investigator will check the patient adherence to the treatment, the control of patient symptoms with functioning neuroendocrine tumor, and disease free survival. Also will be performed an analysis of immunohistochemical expression of mTOR pathway proteins of these patients.


Condition or disease Intervention/treatment Phase
Well-differentiated Neuroendocrine Tumors Drug: Metformin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE II PILOT STUDY OF METFORMIN TREATMENT IN PATIENTS WITH WELL-DIFFERENTIATED NEUROENDOCRINE TUMORS
Study Start Date : March 2014
Estimated Primary Completion Date : December 2017


Arm Intervention/treatment
Experimental: METFORMIN
850mg of metformin every 12 hours.
Drug: Metformin



Primary Outcome Measures :
  1. Disease free survival [ Time Frame: After 180 days of treatment. ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events Related to Metformin Measured of Safety and Tolerability [ Time Frame: Assessments will be performed until 180 days after treatment initiation ]
    Clinical evaluation of metformin related toxicity will be assessed at each medical visit (once a month).

  2. Clinical benefit [ Time Frame: Assessments will be performed until 180 days after treatment initiation. ]
    Clinical benefit will be measured using CTCAE version 4.03 for analysis of adverse events presented by patients.

  3. Biochemical response [ Time Frame: Assessment will be performed at day 90 and 180 of treatment. ]
    Biochemical response defined by tumor markers.

  4. Evaluation of patient`s glycemic profile [ Time Frame: Assessment will be performed at day 90 and day 180 of treatment. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic well-differentiated neuroendocrine tumor grade 1 or 2 with histological confirmation;
  • Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2;
  • Able to take pills;
  • Age ≥ 16 years;
  • Ability to Provide Written Informed Consent;
  • Adequate organ function;

Exclusion Criteria:

  • Patient with out of control severe hormonal syndrome;
  • Diabetic patients under metformin treatment, or those who have received treatment with metformin within 3 months;
  • Patient with hypersensitivity to biguanides, kidney or liver failure, or other conditions that predispose to lactic acidosis;
  • History of severe clinical or psychiatric illness, that would prevent participation in the study by clinical judgment;
  • Patients who participate in other protocol with experimental drugs;
  • Patients under any kind of active infection;
  • Patients who have received chemotherapy within 3 weeks;
  • Patients pregnant or lactating;
  • Diabetic patients who require higher dose of metformin 850mg x 2 daily;

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): NCT02279758


Contacts
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Contact: João Glasberg, MD 55 11 38932000 pesquisa.clinica@icesp.org.br
Contact: Rachel Riechelmann, MD 55 11 38932000 pesquisa.clinica@icesp.org.br

Locations
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Brazil
Instituto do Cancer do Estado de São Paulo Recruiting
Sao Paulo, SP, Brazil, 01246-000
Contact: João Glasberg, MD    55 11 38932000    pesquisa.clinica@icesp.org.br   
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
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Principal Investigator: João Glasberg, MD Instituto do Cancer do Estado de São Paulo

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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT02279758     History of Changes
Other Study ID Numbers: NP 515/2014
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014

Keywords provided by Instituto do Cancer do Estado de São Paulo:
Neuroendocrine Tumors
The Mammalian Target of Rapamycin (mTOR)
metformin

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs