Metformin in Stage IV Lung Adenocarcinoma

NCT01997775 | Terminated Phase 2

• 1 other identifier: B-BR-102-039
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-small Cell Lung Cancer

Keywords

IL-6; Metformin; Non-small cell lung cancer; Lung adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• The change of plasma IL-6 level after the treatment with metformin

  12 weeks

Secondary Outcomes (5)

• The objective response rate (RR)

  2 YEARS

• The progression free survival

  2 years

• The overall survival

  2-years

• Number of participants with adverse events

  2-years

• Changes of quality of life

  2-years

Study Arms (1)

METFORMIN

EXPERIMENTAL

For patients with stage IV lung adenocarcinoma and IL-6 level higher than 2.0 pg/ml after 2 cycles of standard treatment, metformin 500mg tid orally will be given.

Drug: METFORMIN

Interventions

METFORMIN DRUG

Participants enrolled in this study will be treated with either chemotherapy (Cisplatin 75mg/m2 plus Pemetrexed 500mg/m2 on D1) for 4 cycles or targeted therapy (Gefitinib 250mg/d) till disease progression according to physicians' decision. For participants with plasma IL-6 \> 2.0 pg/mL after 2 cycles of chemotherapy or targeted therapy, Metformin 500mg orally qd will be given on Day 1 of cycle 3. If patient could tolerate it well, metformin will be titrated to 500mg bid in the following week (Cycle 3 D8) and 500mg tid in the 3rd week (Cycle 3 D15). For patients receiving chemotherapy, metformin will be used for total 12 weeks and plasma IL-6 level will be checked at the end of metformin treatment. For patients receiving targeted therapy, metformin will be used till disease progression and plasma IL-6 level will be measured after use of metformin for 12 weeks.

Also known as: GLUCOPHAGE

METFORMIN

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed lung adenocarcinoma.
• Stage IV disease as defined by AJCC 7th edition staging.
• At least one measurable lesion (as defined by RECIST v1.1).
• 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).
• Age ≤ 80 years old and ≥ 20 years old.
• ECOG performance status of 0-2.
• 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)
• Estimated life expectancy of at least 6 months.
• Written (signed) Informed Consent.

You may not qualify if:

• 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.
• Use of other anti-cancer therapy, including chemotherapy, target therapy, immunotherapy, radiotherapy, and hormone therapy.
• Prior participation in any investigational drug study within 28 days.
• Use of anti-IL-6 or IL-6-lowering agents.
• Use of metformin in the past 6 months.
• Poor controlled diabetes (HbA1c ≥ 8.0%).
• Known hypersensitivity or intolerance to metformin.
• Congestive heart failure with NYHA functional class II\~IV.
• History of lactic acidosis.
• 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).
• Active uncontrolled infections or HIV infection.
• Psychiatric disorders that would compromise the patient's compliance or decision.
• Current or planned pregnancy, or breast feeding in women.
• Poor compliance.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung Uni. Hosp.

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Metformin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• YUMIN YEH, MD

  NATIONAL CHENG-KUNG UNI. HOSP.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 17, 2013
• First Posted: November 28, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)