NCT03587662

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

Phase II Trial of Ixazomib Combined With Gemcitabine and Doxorubicin in Patients With Renal Medullary Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well ixazomib, gemcitabine, and doxorubicin work in treating patients with kidney cancer that has spread to other places in the body (locally advanced or metastatic). Ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and doxorubicin, 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. Giving ixazomib, gemcitabine, and doxorubicin may work better in treating patients with kidney cancer.

Detailed description

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.

Conditions

• Metastatic Kidney Medullary Carcinoma
• Metastatic Renal Cell Carcinoma
• SMARCB1 Negative
• Stage III Renal Cell Cancer AJCC v8
• Stage IV Renal Cell Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Doxorubicin	Given IV
DRUG	Doxorubicin Hydrochloride	Given IV
DRUG	Gemcitabine	Given IV
DRUG	Gemcitabine Hydrochloride	Given IV
DRUG	Ixazomib	Given PO
DRUG	Ixazomib Citrate	Given PO

Timeline

• Start date: 2018-08-17
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2018-07-16
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study