Stage IV Breast Cancer Clinical Trial
Official title:
Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors.
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as vinorelbine ditartrate, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving temsirolimus together with vinorelbine ditartrate may kill more
tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving
temsirolimus and vinorelbine ditartrate together in treating patients with unresectable or
metastatic solid tumors.
PRIMARY OBJECTIVES:
I. To determine the maximal tolerated dose (MTD) for the combination of temsirolimus and
vinorelbine in advanced solid tumors.
II. To obtain preliminary information regarding the activity of this combination.
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of this combination.
OUTLINE:
Patients receive temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22 and vinorelbine
ditartrate IV over 5-10 minutes on days 1 and 15. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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