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

Roche

Status and phase: Completed; Phase 2

Conditions: Urinary Tract Cancer

Treatments: Drug: gemcitabine; Drug: cisplatin; Drug: trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006667

ML17600

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Trastuzumab, Gemcitabine, Cisplatin

Experimental group

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.

Treatment:

Drug: trastuzumab

Drug: gemcitabine

Drug: cisplatin