Recurrent Breast Carcinoma Clinical Trial
Official title:
Phase I/II Trial of IMC-A12 in Combination With Temsirolimus in Patients With Metastatic Breast Cancer
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.
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.
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