NCT01375829

Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Phase I Study of Ixabepilone and Temsirolimus in Adult Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Ixabepilone	Given IV
OTHER	Pharmacological Study	Correlative studies
DRUG	Temsirolimus	Given IV

Timeline

• Start date: 2011-06-27
• Primary completion: 2018-06-26
• Completion: 2027-03-19
• First posted: 2011-06-17
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States