Temsirolimus in Combination With Metformin in Patients With Advanced Cancers

Summary

This phase I trial studies the side effects and best dose of temsirolimus and metformin hydrochloride in treating patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced or metastatic). Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Metformin hydrochloride is a drug used to treat diabetes that may also prevent or slow the growth of cancers. Giving temsirolimus and metformin hydrochloride together may kill more tumor cells.

Timeline

Start

2012-03-26

Primary completion

2025-03-14

Completion

2025-03-14

Publications

• Ahmed J, Stephen B, Khawaja MR, Yang Y, Salih I, Barrientos-Toro E, Raso MG, Karp DD, Piha-Paul SA, Sood AK, Ng CS, Johnson A, Soliman PT, Meric-Bernstam F, Lu KH, Naing A. A phase I study of temsirolimus in combination with metformin in patients with advanced or recurrent endometrial cancer. Gynecol Oncol. 2025 Feb;193:73-80. doi: 10.1016/j.ygyno.2024.12.019. Epub 2025 Jan 8.
• Liu X, Lorusso P, Mita M, Piha-Paul S, Hong DS, Fu S, McQuinn L, Asatiani E, Doyle LA, Chen HX, Hess KR, Kurzrock R, Naing A. Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response. Oncologist. 2014 Apr;19(4):426-8. doi: 10.1634/theoncologist.2013-0231. Epub 2014 Mar 25.

Drugs

Indications