Conditions: Urinary Tract Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

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:

Arms:
arm 1: 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.

Interventions: intervention 1: trastuzumab intervention 2: gemcitabine intervention 3: cisplatin
Intervention descriptions: intervention 1: 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 intervention 2: 1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6 intervention 3: 70 mg/m2 i.v. on Day 2 of Cycles 1 through 6

Protocol document: