NCT02122172 · REGISTRY CONDITION SEARCH

Afatinib in Advanced Refractory Urothelial Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2025-04-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Overall Response Rate

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outcome · POSTED

Median Progression-free Survival (PFS ) Time

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outcome · POSTED

Median Overall Survival (OS) Time

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outcome · POSTED

EGFR Expression Status

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outcome · POSTED

HER2 Expression Status

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outcome · POSTED

Presence of Tumor Micro Ribonucleic Acids (RNAs) Like miR-200

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outcome · POSTED

Epithelial to Mesenchymal Transition States

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: afatinib dimaleate
Other: laboratory biomarker analysis
label
Treatment (afatinib)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (afatinib)
description
Given PO
name
afatinib dimaleate
other Names
afatinib
BIBW 2992 MA2
Gilotrif
type
DRUG
arm Group Labels
Treatment (afatinib)
description
Correlative studies
name
laboratory biomarker analysis
type
OTHER

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 32
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Relationship to 3-month PFS will be determined.
measure
Presence of Tumor Micro Ribonucleic Acids (RNAs) Like miR-200
time Frame
Baseline
measure
Epithelial to Mesenchymal Transition States
time Frame
Up to 3 years

primary Outcomes

description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated at 3 months using the Kaplan-Meier method.
measure
Progression-free Survival (PFS)
time Frame
3 months

secondary Outcomes

description
Includes both complete responses (CR) and partial responses (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR) is defined as the disappearance of all target lesions (any pathological lymph nodes must have reduction in short axis to \<10 mm); Partial Response (PR) is defined as \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
measure
Overall Response Rate
time Frame
Up to 3 years
description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and the sum must also demonstrate an absolute increase of at least 5mm, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. Estimated using the Kaplan-Meier method.
measure
Median Progression-free Survival (PFS ) Time
time Frame
Up to 3 years
description
Estimated using the Kaplan-Meier method.
measure
Median Overall Survival (OS) Time
time Frame
Up to 3 years
description
These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was EGFR amplification.
measure
EGFR Expression Status
time Frame
Baseline
description
These analyses were conducted using available archival formalin-fixed, paraffin-embedded sections from surgical specimens. Each sample was tested to determine whether there was HER2 amplification.
measure
HER2 Expression Status
time Frame
Baseline

Full study description

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: PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: 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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
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source url
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payload
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id
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nct id
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occurrences
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end
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exact text
NCT02122172
start
0
offset unit
unicode_code_points
query cond
Urethral Cancer
query disease state id
ds-urethral-cancer
source file
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source file sha256
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source json pointer
/studies/24/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
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source string basis
parsed_JSON_string_unmodified
source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Urethral+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice