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Trial record 11 of 55 for:    cancer AND energy restriction

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (METRO)

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: NCT02019979
Recruitment Status : Terminated (PI left the institution)
First Posted : December 24, 2013
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center

Brief Summary:
Metformin is thought to activate AMP-activated protein kinase (AMPK), a major sensor of cellular energy levels and a key enzyme limiting cellular growth during times of cellular stress. Once activated, this enzyme restricts anabolic processes such as protein, cholesterol and fatty acid synthesis and inhibits mTOR, a protein kinase responsible for unregulated growth. MTOR is upregulated in a variety of tumors, including NSCLC providing rationale to take advantage of this pathway with metformin.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Stage IIIB/IV Non-small Cell Lung Cancer Metastatic Nonsquamous Nonsmall Cell Neoplasm of Lung Drug: metformin Behavioral: carbohydrate restricted diet Phase 2

  Show Detailed Description

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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: Metformin With a Carbohydrate Restricted Diet In Combination With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) - METRO Study
Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: metformin /carbohydrate restricted diet
metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen
Drug: metformin
Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

Behavioral: carbohydrate restricted diet
addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
Other Name: dietary counseling




Primary Outcome Measures :
  1. Progress Free Survival [ Time Frame: Time after day 1 cycle 1 to first disease progression for up to 20 months ]
    Progress Free Survival (PFS) is defined as the time from the date of the first dose of treatment to the earlier of the dates of first disease progression per RECIST 1.1 or death from any cause.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 30 months ]
    Overall survival (OS) is defined as time from date of first dose to date of death from any cause.

  2. Number of Participants With LKBI Mutation [ Time Frame: 6 months ]
    To evaluate LKBI mutations as a potential bio-marker to predict subjects who will benefit most from metformin in combination with a carbohydrate restricted diet



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. Able to provide written consent and is amenable to compliance with protocol schedules and testing
  2. Patient is > 18 years of age
  3. Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIB or IV non-squamous non-small cell lung cancer
  4. No prior, palliative chemotherapy for stage IV lung cancer Patients who have received adjuvant chemotherapy post surgery for curative intent more than 12 months prior to development of stage IV disease are allowed.
  5. Measurable disease as RECIST criteria 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
  6. CT Scan of the chest/abdomen/pelvis or PET Scan within 30 days of study entry
  7. An MRI of the brain or Head CT Scan with contrast within 30 days of study entry if clinically indicated
  8. ECOG Performance Status 0-2.
  9. CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

    • Absolute neutrophil count (ANC) >1,500 cells/ul
    • Platelets > 100,000 cells/ul
    • Hemoglobin > 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > g/dl is acceptable.)
  10. Serum creatinine < 1.5 x ULN
  11. Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
  12. AST and ALT < 3.0 x the ULN
  13. Women of childbearing potential must have:

    • A negative serum or urine pregnancy test (sensitivity <= 25IU HCG/L) within 14 days prior to the start of study drug administration
    • Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 90 days after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
  14. Ability to take oral medication

Exclusion Criteria:

  1. The patient has a diagnosis of squamous cell carcinoma. Adenosquamous (mixed) histologies are allowed
  2. The patient has a history of type I or type II diabetes
  3. Weight of less than 80% of (IBW) ideal body weight
  4. Creatinine clearance less than 45 l/min as calculated by the Cockcroft-Gault equation
  5. Known EGFR or ALK mutation in which targeted therapy with erlotinib or crizotinib would be the standard of care. Those patients whose tissue is not tested or have insufficient material are eligible
  6. The patient is currently taking or has previously taken metformin in the past 6 months
  7. The patient has received previous chemotherapy for NSCLC except in instances of adjuvant therapy post surgical resection more than 12 months prior to enrollment
  8. The patient has undergone major surgery within four weeks prior to randomization.
  9. The patient has undergone palliative radiation (chest, brain) to tumor sites within two weeks of randomization (except palliative radiation to the bone which can be within one week
  10. Uncontrolled (untreated) brain metastasis.
  11. Patient who has NCI-CTCAE Version 4 Grade >= 2 diarrhea
  12. That patient has clinically relevant CAD or uncontrolled CHF
  13. The patient has ongoing or active infection (requiring antibiotics) that would limit the administration of chemotherapy including active TB. HIV is allowed in this study
  14. The patient has a history of neurological or psychological disorder that may interfere with the compliance of the protocol
  15. Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding

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): NCT02019979


Locations
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United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Beth Israel Comprehensive Cancer Center
New York, New York, United States, 10011
St.Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Mount Sinai Ichan School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Beth Israel Medical Center
St. Luke's-Roosevelt Hospital Center
Investigators
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Principal Investigator: Benjamin Levy, M.D. Beth Israel Medical Center

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Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02019979     History of Changes
Obsolete Identifiers: NCT02254512
Other Study ID Numbers: METRO 090-13
First Posted: December 24, 2013    Key Record Dates
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018
Last Verified: March 2018

Keywords provided by Beth Israel Medical Center:
non squamous
non small cell
lung cancer
metformin

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Bronchial Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs