Phase 2
N=13
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
Urinary Tract Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02006667 ↗Enrolled (actual)
13
Serious AEs
61.5%
Results posted
Feb 2015
Primary outcome: Primary: Progression-Free Survival (PFS) - Percentage of Participants With an Event — 92.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- trastuzumab (Drug); gemcitabine (Drug); cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) - Percentage of Participants With an Event |
92.3 | — |
| PRIMARY Progression-Free Survival - Time to Event |
11.0 | — |
| PRIMARY Percentage of Participants Who Were Progression Free at 12 and 24 Months |
38.5; 15.4 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
84.6 | — |
| SECONDARY Overall Survival - Time to Event |
14.9 | — |
| SECONDARY Percentage of Participants Surviving at 12 and 24 Months |
76.9; 23.1 | — |
| SECONDARY Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) |
15.4; 23.1; 46.2; 15.4; 38.5; 84.6 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02006667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.