Ixazomib + Chemotherapy for Kidney Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received anticancer therapies within 2 weeks before starting the trial, and certain medications like strong CYP3A inducers are not allowed within 14 days before the first dose of ixazomib. It's best to discuss your current medications with the trial team to ensure eligibility.
Is the combination of Ixazomib and Doxorubicin safe for treating kidney cancer?
How is the drug Ixazomib + Chemotherapy for Kidney Cancer different from other treatments?
The combination of Ixazomib with Doxorubicin and Gemcitabine for kidney cancer is unique because it includes Ixazomib, a proteasome inhibitor, which is not commonly used in standard kidney cancer treatments. This combination may offer a novel approach by potentially enhancing the effectiveness of chemotherapy through a different mechanism of action.16789
What data supports the effectiveness of the drug combination Ixazomib and Doxorubicin for kidney cancer?
The research does not provide direct evidence supporting the effectiveness of Ixazomib and Doxorubicin for kidney cancer. However, one study showed that doxorubicin, when intensified in combination with other drugs, significantly reduced tumor volume in a specific type of kidney cancer (malignant rhabdoid tumor of the kidney).3691011
Who Is on the Research Team?
Pavlos Msaouel
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with advanced or metastatic kidney cancer, including rare types like RMC and rhabdoid tumors. Eligible participants may have had prior treatments but must show disease progression. They need to be over 12 years old, in fairly good health (ECOG 0-2), and meet specific blood count and organ function criteria. Those with controlled brain metastases can join if they meet certain conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive ixazomib orally, gemcitabine intravenously over 90 minutes, and doxorubicin intravenously over 15-30 minutes on day 1. Treatment repeats every 14 days for up to 13 cycles.
Maintenance
Patients receive ixazomib orally and gemcitabine intravenously over 90 minutes. Cycles repeat every 14 days for up to 2 years.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion at 30 and 90 days, then every 3 months thereafter.
What Are the Treatments Tested in This Trial?
Interventions
- Doxorubicin
- Gemcitabine
- Ixazomib
Doxorubicin is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator