Breast Cancer Clinical Trial
Official title:
A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some
of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when
given together with temsirolimus in treating patients with metastatic or unresectable solid
tumor or lymphoma.
OBJECTIVES:
Primary
- To establish the maximum tolerated dose and recommended phase II dose of metformin
hydrochloride when administered with temsirolimus in patients with advanced solid
cancers or lymphoma.
Secondary
- To determine the toxicity and safety, with particular reference to glucose and lipid
deregulation, of this regimen in these patients.
- To assess antitumor activity, including tumor response rate and time to progression, in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive oral metformin once, twice, or three times daily on days 1-28 and
temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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