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BRIEF TITLE: Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer

Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer

  • Org Study ID: 13-0540
  • Secondary ID: NCI-2014-00859,IRB13-0540,13-0540/ 1200.171,P30CA014599
  • NCT ID: NCT02122172
  • NCT Alias:
  • Sponsor: University of Chicago - Other
  • Source: University of Chicago

Brief Summary

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.

Detailed Description


I. To determine the 3-month progression free survival (PFS) rate in metastatic urothelial
cancer patients receiving afatinib (afatinib dimaleate) 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 determine whether tumor epidermal growth factor receptor (EGFR) and/or HER2
overexpression influences 3-month PFS in patients treated with afatinib.


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

After completion of study treatment, patients are followed up every 3 months.

Overal Status Start Date Phase Study Type
Recruiting October 30, 2013 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Progression-free survival (PFS)

Primary Outcome 1 - Time Frame: 3 months


  • Distal Urethral Cancer
  • Proximal Urethral Cancer
  • Recurrent Bladder Cancer
  • Recurrent Urethral Cancer
  • Stage III Bladder Cancer
  • Stage III Urethral Cancer
  • Stage IV Bladder Cancer
  • Stage IV Urethral Cancer
  • Ureter Cancer


Inclusion Criteria:

- Patients must have locally advanced or metastatic urothelial cancer that is not
amenable to surgical treatment

- Patients must have histologically or cytologically confirmed urothelial tract
carcinoma; patients with urothelial carcinoma of the bladder, upper tract, or urethra
are eligible

- 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])

- Patients must have evidence of disease progression prior to enrollment

- 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 up to one line of prior systemic chemotherapy for
recurrent/metastatic disease; if a platinum-based regimen was received both in the
peri-operative setting and again in the metastatic setting, this will be considered 1
line of chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 100,000/mcL

- Hemoglobin >= 8.5g/dL

- Total bilirubin =< 1.5 institutional upper limit of normal (IULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT])
=< 2.5 X IULN

- 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

- 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

- Patients must have the ability to understand and the willingness to sign a written
informed consent document

Exclusion Criteria:

- Patients may not be receiving any other investigational agents

- Patients with untreated known brain metastases, or treated brain metastases that are
clinically unstable

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
psychiatric illness/social situations that would limit compliance with study

- Women known to be pregnant

- Women who are breastfeeding and who are unwilling to stop breastfeeding prior to study

- Patients with known prior human immunodeficiency virus (HIV)-positive status on
combination antiretroviral therapy are ineligible; known prior HIV-positive patients
with CD4+ =< 500/mm^3 are ineligible (HIV testing is not required as part of this

- Pre-existing interstitial lung disease

- Inability to take oral medications

- Prior therapy with afatinib
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Peter O'Donnell

Role: Principal Investigator

Affiliation: University of Chicago


Facility Status Contact
University of Chicago
Chicago, Illinois 60637
United States
Recruiting Peter H. O'Donnell
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Recruiting James L. Wade
NorthShore University Health System
Evanston, Illinois 60201
United States
NYU Langone Health
New York, New York 10016
United States
Recruiting Kaitlyn Francese
University of North Carolina - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Recruiting Anly Thomas