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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Percentage of Participants Who Were Progression Free at 12 and 24 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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+]).
排除标准
- •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.
研究组 & 干预措施
Trastuzumab, Gemcitabine, 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.
干预措施: trastuzumab (Drug)
Trastuzumab, Gemcitabine, 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.
干预措施: gemcitabine (Drug)
Trastuzumab, Gemcitabine, 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.
干预措施: cisplatin (Drug)
结局指标
主要结局
Percentage of Participants Who Were Progression Free at 12 and 24 Months
时间窗: Screening, and Months 12 and 24
Progression-Free Survival (PFS) - Percentage of Participants With an Event
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Overall Survival - Time to Event(Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months)
- 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)