Afatinib for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byPeter O'Donnell

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that cannot be removed surgically and has grown after treatment with standard first-line chemotherapy. Afatinib dimaleate may turn off the function of the epidermal growth factor (EGF) and human epidermal growth factor receptor 2 (HER2) receptors, which may slow the growth of cancer cells or cause some of the cells to die.

Eligibility Criteria

This trial is for adults with advanced urothelial cancer that surgery can't remove and has worsened after first-line chemo. They must have had platinum-based chemo, measurable disease, good organ function, not be pregnant or breastfeeding, agree to use contraception, and not have certain health issues like brain metastases or severe lung disease.

Inclusion Criteria

Your platelet count is at least 100,000 per microliter.

My cancer is confirmed to be urothelial carcinoma.

I have urothelial cancer and platinum-based treatments no longer work for me.

+12 more

Exclusion Criteria

I do not have HIV or my HIV is well-controlled without needing combination antiretroviral therapy.

I have brain metastases that are either untreated or not stable after treatment.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

+6 more

Participant Groups

The study tests afatinib dimaleate's effectiveness on patients with urothelial cancer resistant to standard chemotherapy. It targets EGF and HER2 receptors in cancer cells to potentially slow growth or cause cell death. Participants' response to the drug is monitored through lab biomarker analysis.

1Treatment groups

Experimental Treatment

Group I: Treatment (afatinib)Experimental Treatment2 Interventions

Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.