Metformin in Stage IV Lung Adenocarcinoma
Information source: National Cheng-Kung University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-small Cell Lung Cancer
Intervention: METFORMIN (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Cheng-Kung University Hospital Official(s) and/or principal investigator(s): YUMIN YEH, MD, Principal Investigator, Affiliation: NATIONAL CHENG-KUNG UNI. HOSP.
Overall contact: YUMIN YEH, MD, Phone: 886-6-2353535, Ext: 4559, Email: i5485111@gmail.com
Summary
The purpose of this study is to determine whether metformin is effective in lowering plasma
IL-6 level and improving the treatment response in patients with non-small cell lung cancer
Clinical Details
Official title: A Phase II Trial to Examine the Effect of Metformin on Plasma IL-6 Level in Patients With Advanced Non-Small Cell Lung Cancer
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: The change of plasma IL-6 level after the treatment with metformin
Secondary outcome: The objective response rate (RR)The progression free survival The overall survival Number of participants with adverse events Changes of quality of life
Detailed description:
Interleukin-6 (IL-6) plays an important role in the pathogenesis of lung cancer. Several
clinical studies show metformin could decrease IL-6 level in addition to the
glucose-lowering effect. Preclinical data also reveal metformin could decrease the IL-6
production in lung cancer cells and enhance cytotoxicity of chemotherapy in animal model.
Based on these findings, the purpose of this study is to determine whether metformin is
effective in lowering plasma IL-6 level and improving the treatment response in patients
with non-small cell lung cancer clinically. Patients with stage IV lung adenocarcinoma will
be enrolled in this study and receive standard treatments for lung cancer, either
chemotherapy combining cisplatin and pemetrexed or targeted therapy (Gefitinib). For
patients with plasma IL-6 more than 2. 0 pg/ml after 2 cycles of standard treatment,
metformin will be given and titrated to 1500mg/day gradually. Plasma IL-6 level will be
checked after use of metformin for 12 weeks. Tumor response to the standard treatment plus
metformin will be evaluated and side effects of metformin will also be monitored.
Eligibility
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed lung adenocarcinoma.
2. Stage IV disease as defined by AJCC 7th edition staging.
3. At least one measurable lesion (as defined by RECIST v1. 1).
4. No prior radiotherapy, chemotherapy, surgery, target therapy, or immunotherapy for
NSCLC. (Except the surgery for biopsy or port-A implantation, palliative localized
radiotherapy for bone metastasis).
5. Age ≤ 80 years old and ≥ 20 years old.
6. ECOG performance status of 0-2.
7. Adequate organ function, including followings
Bone marrow:
Absolute neutrophil count (ANC) ≥ 1. 5 x 10^9/L; WBC ≥ 3. 0 x 10^9/L Platelet count ≥
100 x 10^9/L Hemoglobin ≥ 9g/dL
Hepatic:
Total bilirubin level ≤ 1. 0 x UNL AST and ALT ≤ 3. 0 x UNL;
Renal:
Creatinine level ≤ 1. 5 mg/dL in men, ≤1. 4 mg/dL in women; or Estimated CCr ≥ 60
mL/min. (CCr is estimated by Cockcroft-Gault formula, as appendix II)(CCr is
estimated by Cockcroft-Gault formula)
8. Estimated life expectancy of at least 6 months.
9. Written (signed) Informed Consent.
Exclusion Criteria:
1. With other primary malignancies, except those remain disease-free for 3 or more years
after curative treatment, basal cell cancer of the skin or in situ cervical cancer.
2. Use of other anti-cancer therapy, including chemotherapy, target therapy,
immunotherapy, radiotherapy, and hormone therapy.
3. Prior participation in any investigational drug study within 28 days.
4. Use of anti-IL-6 or IL-6-lowering agents.
5. Use of metformin in the past 6 months.
6. Poor controlled diabetes (HbA1c ≥ 8. 0%).
7. Known hypersensitivity or intolerance to metformin.
8. Congestive heart failure with NYHA functional class II~IV.
9. History of lactic acidosis.
10. Significant concurrent medical diseases, such as unstable angina, acute or recent
myocardial infarction (< 6 months before enrollment), COPD with frequent
exacerbation, uncontrolled hypertension, or recent CVA (< 6 months before
enrollment).
11. Active uncontrolled infections or HIV infection.
12. Psychiatric disorders that would compromise the patient's compliance or decision.
13. Current or planned pregnancy, or breast feeding in women.
14. Poor compliance.
Locations and Contacts
YUMIN YEH, MD, Phone: 886-6-2353535, Ext: 4559, Email: i5485111@gmail.com
National Cheng-Kung Uni. Hosp., Tainan 704, Taiwan; Recruiting LISA YANG, SC, Phone: 886-6-2353535, Ext: 4289, Email: lisayang0416@gmail.com YU-MIN YEH, MD, Principal Investigator
Additional Information
Starting date: August 2013
Last updated: November 24, 2013
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