Ixazomib, Gemcitabine, and Doxorubicin in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

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PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) and disease control rate (DCR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of ixazomib with gemcitabine and doxorubicin. SECONDARY OBJECTIVE: I. To determine the overall ...

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR) and disease control rate (DCR) of patients with locally advanced or metastatic renal medullary carcinoma (RMC) treated with combination of ixazomib with gemcitabine and doxorubicin. SECONDARY OBJECTIVE: I. To determine the overall survival (OS), progression-free survival (PFS), duration of response (DOR) and safety of the combination of ixazomib with gemcitabine and doxorubicin in patients with RMC. EXPLORATORY OBJECTIVES: I. To evaluate potential biomarkers, such as tumor tissue protein disulfide isomerase (PDI), binding immunoglobulin protein (BiP), and phosphorylated eIF2a (eIF2aP), as well as serum levels of interleukin 6 (IL-6), for patient stratification, and as pharmacodynamics measures of treatment response. II. To determine, via the molecular profiling of biopsy and blood speciments, the mechanisms of resistance to the trial therapy (ixazomib + gemcitabine + doxorubicin). OUTLINE: INDUCTION: Patients receive ixazomib orally (PO), gemcitabine intravenously (IV) over 90 minutes, and doxorubicin IV over 15-30 minutes on day 1. Treatment repeats every 14 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive ixazomib PO and gemcitabine IV over 90 minutes. Cycles repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days, then every 3 months thereafter.

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