Stage IV Bladder Cancer Clinical Trial
Official title:
Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer
Verified date | May 2024 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 95 |
Est. completion date | April 4, 2024 |
Est. primary completion date | April 4, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 immediately - 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 requirements - Women known to be pregnant - Women who are breastfeeding and who are unwilling to stop breastfeeding prior to study entry - 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 study) - Pre-existing interstitial lung disease - Inability to take oral medications - Prior therapy with afatinib |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Winship Cancer Institute | Atlanta | Georgia |
United States | University of North Carolina - Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | University of Chicago | Chicago | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | NorthShore University Health System | Evanston | Illinois |
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Presence of tumor micro ribonucleic acids (RNAs) like miR-200 | Relationship to 3-month PFS will be determined. | Baseline | |
Other | Epithelial to mesenchymal transition states | Up to 3 years | ||
Other | Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | Up to 28 days after last administration of trial drugs | ||
Primary | Progression-free survival (PFS) | Estimated using the Kaplan-Meier method. | 3 months | |
Secondary | Overall response rate (CR + PR) | Up to 3 years | ||
Secondary | Median progression-free survival (PFS ) time | Estimated using the Kaplan-Meier method. | Up to 3 years | |
Secondary | Overall survival | Estimated using the Kaplan-Meier method. | Up to 3 years | |
Secondary | EGFR expression status | Relationship to 3-month PFS will be determined. | Baseline | |
Secondary | HER2 expression status | Relationship to 3-month PFS will be determined. | Baseline |
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