Ixazomib + Gemcitabine + Doxorubicin for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen byArlene O Siefker-Radtke

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of ixazomib citrate, gemcitabine hydrochloride, and doxorubicin hydrochloride when given together in treating patients with urothelial cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery. Ixazomib citrate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as gemcitabine hydrochloride and doxorubicin hydrochloride, 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 citrate together with gemcitabine hydrochloride and doxorubicin hydrochloride may be a better treatment for urothelial cancer.

Eligibility Criteria

This trial is for adults with urothelial cancer that has spread or can't be removed by surgery. They must have had at least one prior therapy, unless they cannot or refuse cisplatin-based therapy. Participants should not be pregnant, breastfeeding, or planning to become pregnant and must agree to use effective contraception. They need a certain level of heart, liver, and kidney function and cannot have severe heart disease, active infections like hepatitis B/C or HIV, unstable angina, significant neuropathy (nerve pain), recent major surgery or other clinical trials within the last month.

Inclusion Criteria

I haven't been treated with specific cancer drugs before for my condition.

My heart pumps well despite past heart issues or specific cancer treatment.

I am a male and agree to follow the birth control requirements.

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Exclusion Criteria

I haven't had a heart attack in the last 6 months and don't have severe heart issues.

I am not on IV antibiotics for an infection.

I don't have GI issues that affect medicine absorption or swallowing.

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Treatment Details

Interventions

Doxorubicin Hydrochloride (Anti-tumor antibiotic)
Gemcitabine Hydrochloride (Anti-metabolite)
Ixazomib Citrate (Proteasome Inhibitor)

Trial OverviewThe trial tests ixazomib citrate combined with chemotherapy drugs gemcitabine hydrochloride and doxorubicin hydrochloride on patients with advanced urothelial cancer. It aims to find the best dose while assessing how well this combination works in stopping tumor growth compared to current treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib, gemcitabine, doxorubicin)Experimental Treatment3 Interventions

Patients receive ixazomib citrate PO, gemcitabine hydrochloride IV over 90 minutes, and doxorubicin hydrochloride IV over 15-30 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Doxorubicin Hydrochloride is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Adriamycin for: