This phase I trial studies the side effects and best dose of ixabepilone and temsirolimus in treating patients with solid tumors that have spread from the primary site to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ixabepilone together with temsirolimus may kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of the combination of ixabepilone and temsirolimus in patients with advanced solid tumors. II. To describe toxicity profiles associated with the combination of ixabepilone and temsirolimus. III. To assess preliminary efficacy of the combination of ixabepilone and temsirolimus. OUTLINE: This is a dose-escalation study. Patients receive ixabepilone intravenously (IV) over 3 hours on day 1 and temsirolimus IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
MTD of the combination of ixabepilone and temsirolimus, defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients)
Time frame: 21 days
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The number and severity of all adverse events (overall, by dose-level, and by tumor group) will be tabulated and summarized in this patient population.
Time frame: Up to 3 months
Incidence of overall toxicity graded according to Common Toxicity Criteria standard grading
Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
Time frame: Up to 3 months
Best response, defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence
Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population (overall and by tumor group).
Time frame: Up to 3 months
Time until any treatment related toxicity
Time frame: Up to 3 months
Time until treatment related grade 3+ toxicity
Time frame: Up to 3 months
Time until hematologic nadirs (white blood cells, absolute neutrophil count, platelets)
Time frame: Up to 3 months
Time to progression
Time frame: Up to 3 months
Time to treatment failure
Time frame: From registration to documentation of progression, unacceptable toxicity, or refusal to continue participation by the patient, assessed up to 3 months
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