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RATIONALE: Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more tumor cells.
- To confirm the safety and tolerability of cixutumumab and temsirolimus in patients with castration-resistant metastatic prostate cancer and a rising PSA. (Phase I)
- To determine the tumor response rate and/or composite time to progression in patients treated with this regimen. (Phase II)
- To determine the maximal percent decrease in PSA from baseline.
- To determine the change in PSA doubling time.
- To determine the time to PSA progression and 6-month progression-free survival.
- To determine the rate of adverse events.
- To evaluate changes in circulating tumor cell (CTC) numbers with time.
- To evaluate IGF1R and AR in CTCs and correlate with response.
- To evaluate profiling CTCs at the molecular level by PCR for prostate cancer-specific genes.
- To explore the association between clinical outcomes, administration of therapy, and serial FDG-PET imaging.
- To correlate 18-FDHT-PET imaging findings with outcome measures of response.
- To perform tumor biopsies and evaluate biomarkers that may correlate with active feedback and tumor response to therapy, including anti-IRS-1, anti-IRS-2, pAkt(S473), p70/S6K, anti-phospho-PRAS 40, and PTEN status.
OUTLINE: This is a multicenter study.
Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients may undergo imaging and serum and tumor tissue sample collection periodically for correlative laboratory studies.
After completion of study treatment, patients are followed at 4 weeks.
Masking: Open Label, Primary Purpose: Treatment
cixutumumab, temsirolimus, laboratory biomarker analysis
University of Chicago Cancer Research Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:17:31-0400
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