A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.

Official Title
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An Open-label Pilot Study of the Effect of Second-line Treatment With Herceptin Monotherapy on Time to Disease Progression in Patients With Metastatic Urothelial Cancer and HER2 Overexpression

Conditions
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Urinary Tract Cancer

Intervention / Treatment
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* Drug: trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients >=18 years of age; metastatic urothelial cancer; disease progression during or after 1 prior platinum-based chemotherapy; measurable disease; HER2 overexpression (IHC [2+] or [3+]). Exclusion Criteria: concomitant chemotherapy or immunotherapy; active or uncontrolled infection; solely CNS metastases; clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea; co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trastuzumab Monotherapy<br>Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by weekly doses of 2 mg/kg IV beginning on Day 8 and continuing for up to 37 weeks. | Drug: trastuzumab<br>* Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.<br>* Other names: Herceptin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause. | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment | 
| Progression-Free Survival - Time to Event | The median time, in months, from the first study drug treatment to a PFS event. | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment | 
| Percentage of Participants Progression Free at 12 and 24 Months |  | Months 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) - Percentage of Participants With an Event | OS was defined as the time from the start of study treatment to date of death due to any cause. | Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter | 
| Overall Survival - Time to Event | The median time, in months, from the start of study treatment to an OS event. | Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter | 
| Percentage of Participants Surviving at 12 and 24 Months |  | Months 12 and 24 | 
| Percentage of Participants by Best Overall Response to Treatment | Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD). | Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment |