NCT00699491

Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial is studying the side effects and best dose of cixutumumab when given together with temsirolimus and to see how well they work in treating patients with breast cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other places in the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways by targeting certain cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may be a better treatment for breast cancer.

Detailed description

PRIMARY OBJECTIVES: I. To establish the recommended dose level for the phase II trial. (Phase I) II. To examine the safety profile of this combination in patients with metastatic breast cancer. (Phase I) III. To assess the anti-tumor activity (in terms of overall response rate) and toxicity profile of IMC-A12 (cixutumumab) in combination with temsirolimus in patients with metastatic breast cancer. (Phase II) SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) and overall survival distributions (as well as the 6-month PFS rate). II. To evaluate the in vivo mechanisms of action of temsirolimus in combination with IMC-A12 and to examine potential biomarker predictors of treatment response. OUTLINE: This is a phase I, dose-escalation study of cixutumumab followed by a phase II study. Patients receive temsirolimus intravenously (IV) over 30 minutes and cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 (cixutumumab is given on days 8, 15, and 22 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 2 (phase I) or 5 (phase II) years.

Conditions

• Male Breast Carcinoma
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer AJCC v6 and v7

Interventions

Type	Name	Description
BIOLOGICAL	Cixutumumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Temsirolimus	Given IV

Timeline

• Start date: 2008-10-31
• Primary completion: 2013-09-09
• Completion: 2018-02-14
• First posted: 2008-06-18
• Last updated: 2018-06-13
• Results posted: 2015-05-21

Locations

192 sites across 1 country: United States