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

Phase 2TerminatedNCT02013765

Hoffmann-La Roche5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Tract Cancer

Interventions

trastuzumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Aschersleben, Germany

Unnamed facility

Dessau, Germany

Unnamed facility

Fulda, Germany

Unnamed facility

Leipzig, Germany

Unnamed facility

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Months 12 and 24

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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).

Data from ClinicalTrials.gov

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