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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Given IV
Given IV
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
To determine the maximum tolerated dose of Temsirolimus and Vinorelbine
Time frame: 1 month up to 18 months
To assess the response rate based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 2 months up to 18 months
To evaluate the safety and tolerability of Temsirolimus and Vinorelbine
Time frame: 4 weeks up to 36 weeks
Progression-free and overall survival
Time frame: Up to 18 months
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