Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
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.
Unspecified Adult Solid Tumor, Protocol Specific
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Ixabepilone and Temsirolimus in Adult Patients With Advanced Solid Tumors|
- 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 ] [ Designated as safety issue: Yes ]
- Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]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.
- Incidence of overall toxicity graded according to Common Toxicity Criteria standard grading [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.
- Best response, defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]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 until any treatment related toxicity [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
- Time until treatment related grade 3+ toxicity [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
- Time until hematologic nadirs (white blood cells, absolute neutrophil count, platelets) [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ixabepilone, temsirolimus)
Patients receive ixabepilone 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.
Other Names:Drug: temsirolimus
Other Names:Other: pharmacological study
Other Name: pharmacological studies
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 therapy, patients are followed up for 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375829
|United States, Florida|
|Mayo Clinic in Florida||Recruiting|
|Jacksonville, Florida, United States, 32224-9980|
|Contact: Michael E. Menefee 904-953-2000 email@example.com|
|Principal Investigator: Michael E. Menefee|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Keith C. Bible 507-538-7623 firstname.lastname@example.org|
|Principal Investigator: Keith C. Bible|
|Principal Investigator:||Michael Menefee||Mayo Clinic|