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

Phase 2CompletedNCT02006667

Hoffmann-La Roche13 enrolled

Overview

This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. 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

4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression

gemcitabineDRUG

1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6

cisplatinDRUG

70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adult patients with \>=18 years of age; * metastatic urothelial carcinoma; * measurable metastases or local recurrent disease; * no prior chemotherapy for metastatic 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 death due to any cause.

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Progression-Free Survival - Time to Event

The median time, in months, from the first dose of study treatment to PFS event.

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months

Percentage of Participants Who Were Progression Free at 12 and 24 Months

Time frame: Screening, and 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, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months

Overall Survival - Time to Event

The median time, in months, from the start of study treatment to OS event.

Time frame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months

Percentage of Participants Surviving at 12 and 24 Months

Time frame: Screening, and Months 12 and 24

Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)

Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): 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 have decreased to normal \[(short axis less than (\<) 10 millimeters (mm)\]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) 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. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).

Data from ClinicalTrials.gov

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