A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer
- Registration Number
- NCT02013765
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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+]).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trastuzumab Monotherapy trastuzumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Progression Free at 12 and 24 Months Months 12 and 24 Progression-Free Survival (PFS) - Percentage of Participants With an Event Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment 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.
Progression-Free Survival - Time to Event Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment The median time, in months, from the first study drug treatment to a PFS event.
- Secondary Outcome Measures
Name Time Method Percentage of Participants by Best Overall Response to Treatment Screening, every 3 months during treatment (up to 37 weeks), and at end of 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).
Overall Survival (OS) - Percentage of Participants With an Event Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter OS was defined as the time from the start of study treatment to date of death due to any cause.
Percentage of Participants Surviving at 12 and 24 Months Months 12 and 24 Overall Survival - Time to Event Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter The median time, in months, from the start of study treatment to an OS event.