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Afatinib Dimaleate in Treating Patients with Advanced Refractory Urothelial Cancer

Cancer Type
Bladder Cancer
Unknown Primary
Urethral Cancer
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
IRB13-0540 (primary)
Study Sponsor
University of Chicago Comprehensive Cancer Center


This phase II trial studies how well afatinib dimaleate works in treating patients with urothelial cancer that has not responded to previous treatment (refractory). Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


I. To determine the 6-month progression free survival (PFS) rate of molecularly-selected metastatic urothelial cancer patients treated with afatinib dimaleate (afatinib) who have progressed despite prior platinum-based chemotherapy.

I. To determine the overall response rate (complete response [CR] + partial response [PR]), median progression free survival, and overall survival for the same treated population.
II. To examine the role of different ErBB alterations in determining afatinib activity in urothelial cancer.

I. To determine whether tumor EGFR and/or HER2 expression, or, alternatively, whether certain micro ribonucleic acid (RNA)s, influence 6-month PFS in patients treated with afatinib.

Patients receive afatinib dimaleate orally (PO) once daily (QD) on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 3 years.


  1. Patients must have locally advanced or metastatic urothelial cancer that is not amenable to surgical treatment
  2. Patients must have histologically or cytologically confirmed urothelial tract carcinoma; patients with urothelial carcinoma of the bladder, upper tract, or urethra are eligible
  3. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan for the evaluation of measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]). Lesions that have been irradiated as the most recent line of treatment are not eligible as RECIST target lesions.
  4. Patients must have evidence of disease progression prior to enrollment
  5. All patients must have received a prior platinum-based chemotherapy regimen for treatment of urothelial cancer and must now be considered refractory to platinum-based chemotherapy; patients may have received the platinum-containing regimen either in the peri-operative or metastatic setting; patients may have received any number of additional prior therapies, and may have received prior immune therapies
  6. Patients must have tumor evidence of somatic genomic molecular alteration in EGFR, HER2, ERBB3, or ERBB4, from a test result generated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory; the tumor tissue sample used to generate the qualifying report must be from a muscle-invasive or higher stage urinary tract cancer specimen (metastatic tissue is also acceptable); final determination about whether a specific tissue source or molecular genomic finding meets criteria as a qualifying result rests with the central study principal investigator (PI); germline genomic findings will not be returned to patients
  7. Patients must be 18 years of age or older
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  9. Absolute neutrophil count >= 1,000/mcL
  10. Platelets >= 100,000/mcL
  11. Hemoglobin >= 8.5 g/dL
  12. Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
  13. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X IULN
  14. Calculated creatinine clearance >= 30 mL/min by the modified Cockcroft and Gault formula OR glomerular filtration rate >= 30 mL/min/body surface area (BSA) by Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  15. Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  16. Patients must have the ability to understand and the willingness to sign a written informed consent document
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE


Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.