Table A1.
Summary of Clinical Trials of Recalcitrant Cancers, Defined as Cancers With a 5-Year Survival of < 50%, That Include Metformin in a Treatment Arm
| Study Characteristic | Cancer Type | |||||
|---|---|---|---|---|---|---|
| Pancreas (n = 11) | Non–Small-Cell Lung Cancer (n = 9) | Ovary (n = 3) | Liver Cancer (n = 1) | Brain (n = 3) | Acute Myeloid Leukemia (n=1) | |
| Status | ||||||
| Completed | 2 | 1 | ||||
| Recruiting | 6 | 8 | 2 | 2 | 1 | |
| Active, not recruiting | 0 | 1 | ||||
| Not yet recruiting | 1 | 1 | ||||
| Terminated | 1 | |||||
| Suspended participant recruitment | 1 | |||||
| Withdrawn before enrollment | 1 | |||||
| Cancer stage | Metastatic (8); metastatic or locally advanced (1); nonmetastatic or recurrent (1); and nonmetastatic (1) | Stage lb (1); stage lb-IIIa (1); stage Ilc/III/IV (1); stage IIIa/IIIb (2); stage IIIb/IV (2); and stage IV (2) | Recurrent (1); stage IIC, III, IV (1); and stage III-IV (1) | Not mentioned (1) | Stage IV astrocytoma (1); recurrent (1); and postcranial or cranial-spinal radiation (1) | Relapsed/refractory disease (1) |
| Primary outcome | ||||||
| Progression-free survival | 3 | 5 | 2 | |||
| Overall survival | 2 | |||||
| Recurrence-free survival | 1 | 1 | ||||
| Others | 5 | 4 | 1 | 3 | 1 | |
| Study phase | ||||||
| I | 3 | 1 | 1 | 2 | 1 | |
| II | 6 | 9 | 2 | |||
| I and II | 2 | |||||
| III | 1 | |||||
| Daily dose of metformin, mg | ||||||
| 2,550 (850 mg thrice daily) | 1 | |||||
| 2,000 | 1 | 6 | ||||
| 1,700 (850 mg twice daily) | 1 | 1 | ||||
| 1,500 | 1 | |||||
| 1,000 | 2 | |||||
| 500 | 2 | |||||
| Not mentioned | 4 | 1 | 3 | 1 | 2 | 1 |
| 1,000 mg/m2 | 1 | |||||
| Prior exposure to metformin | ||||||
| Not mentioned | 3 | 2 | 2 | 1 | ||
| Allowed | 1 | |||||
| Allowed if dose is < 1,000 mg daily | 1 | |||||
| Allowed if on metformin < 6months | 3 | |||||
| No metformin use in previous 6 months | 1 | 3 | 2 | |||
| No metformin use in previous 12 months | 1 | |||||
| Not allowed | 1 | 4 | 1 | 1 | ||
| No metformin use in previous 1 week | 1 | |||||
| History of diabetes | ||||||
| Not mentioned | 4 | 3 | 2 | |||
| Allowed if taking metformin < 6 months | 4 | |||||
| Allowed if not taking metformin | 1 | |||||
| Allowed if not taking metformin within 1 year | 1 | |||||
| Allowed if not taking metformin within 6 months | 1 | |||||
| Allowed | 1 | |||||
| Excluded | 5 | 3 | 1 | 1 | ||
| Included | 1 | |||||
NOTE. Data given as No. unless otherwise noted. Last access on June 1, 2015.