A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
- Conditions
- Urinary Tract Cancer
- Interventions
- Registration Number
- NCT02006667
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 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+]).
- 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, Gemcitabine, Cisplatin trastuzumab 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. Trastuzumab, Gemcitabine, Cisplatin gemcitabine 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. Trastuzumab, Gemcitabine, Cisplatin cisplatin 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Were Progression Free at 12 and 24 Months Screening, and Months 12 and 24 Progression-Free Survival (PFS) - Percentage of Participants With an Event Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months 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.
Progression-Free Survival - Time to Event Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months The median time, in months, from the first dose of study treatment to PFS event.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) - Percentage of Participants With an Event Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months OS was defined as the time from the start of study treatment to date of death due to any cause.
Overall Survival - Time to Event Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months The median time, in months, from the start of study treatment to OS event.
Percentage of Participants Surviving at 12 and 24 Months Screening, and Months 12 and 24 Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months 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).