Bortezomib + Gemcitabine/Doxorubicin for Urothelial Cancer

Palo Alto (17 mi)

Overseen byArlene Siefker-Radtke, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this clinical research study is to find the highest tolerable dose of Gemzar® (gemcitabine) and Adriamycin® (doxorubicin) that can be given together with Velcade® (bortezomib) in patients with urothelial cancer or other solid tumors.

Eligibility Criteria

This trial is for adults with urothelial cancer or other solid tumors without standard treatment options. Participants must have had prior therapy, be able to perform daily activities (Zubrod status ≤2), and not be pregnant or breastfeeding. They should have normal organ function and agree to use birth control. Those with severe heart disease, active second cancers, significant neuropathy, or allergies to the drugs are excluded.

Inclusion Criteria

I am using or willing to use birth control during the study.

My cancer is confirmed by biopsy and has no standard treatment.

My heart's pumping ability is at least 45%, despite past heart issues or specific cancer treatment.

My kidney function tests are within normal range.

I can take care of myself but might not be able to do heavy physical work.

My cancer can be measured or seen on tests.

My liver functions are within normal limits.

Exclusion Criteria

I have another type of cancer that is active or might become active.

I am currently pregnant or breastfeeding.

I have moderate to severe nerve damage in my hands or feet.

It's been over 6 weeks since my pelvic radiation, and less than 10% of my bone marrow was irradiated.

I do not have uncontrolled brain metastases or CNS disease.

Treatment Details

Researchers are testing the highest dose of Gemzar (gemcitabine) and Adriamycin (doxorubicin) that can safely be given with Velcade (bortezomib). The study aims to determine tolerable levels for patients who've exhausted standard treatments for their advanced cancers.

1Treatment groups

Experimental Treatment

Group I: Bortezomib + Gemcitabine + DoxorubicinExperimental Treatment3 Interventions

Starting dose of Bortezomib 0.8 mg/m\^2 IV Over 3-5 Seconds. Starting dose of Gemcitabine 225 mg/m\^2 IV Up to 90 Minutes. Starting dose of Doxorubicin 12.5 mg/m\^2 IV Over 15-30 minutes.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for: