Clinical trial · Interventional
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer
NCT02006667CI-TRIAL-00016842completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Tract Cancer | Malignant Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab, Gemcitabine, Cisplatin
- description
- Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v until disease progression; 1200 mg per square meter (m2) gemcitabine i.v. on Days 1, 8, and 15 of Cycles 1 through 6; and 70 mg/m2 cisplatin i.v. on Day 2 of Cycles 1 through 6.
- interventionNames
- Drug: trastuzumab
- Drug: gemcitabine
- Drug: cisplatin
Primary outcomes (3)
- measure
- Progression-Free Survival (PFS) - Percentage of Participants With an Event
- timeFrame
- Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.