Metformin in Stage IV Lung Adenocarcinoma
|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: NCT01997775|
Recruitment Status : Terminated (Difficult enrollment)
First Posted : November 28, 2013
Last Update Posted : September 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: METFORMIN||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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.
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.
Other Name: GLUCOPHAGE
- The change of plasma IL-6 level after the treatment with metformin [ Time Frame: 12 weeks ]
- The objective response rate (RR) [ Time Frame: 2 YEARS ]
- The progression free survival [ Time Frame: 2 years ]
- The overall survival [ Time Frame: 2-years ]
- Number of participants with adverse events [ Time Frame: 2-years ]All adverse events (AEs) occurring after the patient receiving the first dose of study drug will be monitored and recorded. Periodic measurement of vital signs, regular laboratory evaluation for hematology and blood chemistry will be arranged and these will be graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades.
- Changes of quality of life [ Time Frame: 2-years ]The quality of life will be evaluated by the EQ-5D-3L questionnaire which will be completed at baseline, during the therapy, and post-therapy period
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): NCT01997775
|National Cheng-Kung Uni. Hosp.|
|Tainan, Taiwan, 704|
|Principal Investigator:||YUMIN YEH, MD||NATIONAL CHENG-KUNG UNI. HOSP.|