Temsirolimus in Combination With Metformin in Patients With Advanced Cancers
The goal of this clinical research study is to find the highest tolerable dose of the combination of temsirolimus and metformin that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
Temsirolimus is designed to block a protein called mTOR (a protein that is thought to cause cancer cells to grow) inside the cancer cell. This may interfere with the growth or spread of cancer cells or possibly kill them.
Metformin was designed to treat patients with diabetes. It may be able to block the protein mTOR and slow the growth of tumors.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers|
- Maximum Tolerated Dose (MTD) of Temsirolimus and Metformin [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]MTD defined as highest dose studied in which incidence of dose limiting toxicity (DLT) less than 33%. DLTs defined as adverse events (AEs) related to study agents which occur during first cycle of treatment. Toxicity must have possible, probable or definite attribution to study drugs.
- Clinical Tumor Response [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Clinical efficacy measured by objective tumor response per RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Clinical response defined as Complete Response (CR) or Partial Response (PR) or at least 4 months Stable Disease (SD).
|Study Start Date:||March 2012|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Experimental: Temsirolimus + Metformin
Starting dose of Temsirolimus 25 mg by vein weekly. Metformin titrated over 3 weeks at 500 mg by mouth daily. Four weeks of treatment constitute 1 cycle. Cycle one (1) however, will be 6 weeks long to allow for metformin titration.
Starting dose: 25 mg by vein weekly.
Expansion cohort: Once MTD is determined, or at maximum tolerated dose level explored (Level 5) if MTD is not reached, additional 14 patients enrolled.
Other Names:Drug: Metformin
Starting dose: 500 mg titrated over first 3 weeks.
Expansion cohort: Once MTD is determined, or at maximum tolerated dose level explored (Level 5) if MTD is not reached, additional 14 patients enrolled
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529593
|Contact: Aung Naing, MD||713-563-1930|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||M.D. Anderson Cancer Center|