Phase II clinical trial of Cisplatin, Gemcitabine and Trastuzumab (Herceptin®) as first line treatment of advanced irresectable transitional-cell urothelial carcinoma with overexpression of C-erbB-2 - UROTELIALHER2

ACROSS Group0 个研究点开始时间: 2006年5月8日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Histologically proven diagnosis of urothelial adenocarcinoma of bladder, ureter and renal pelvis with overexpression of C-erbB-2 determined by IHC (+++) or FISH/CISH (in IHC ++)
•- Non-resectable metastasic or locally advanced disease at the time of inclusion. Any T, any N and M1; T4b, N0, M0 or any T , N1,2 or 3, M0
•- Presence of at least one dimensionally measurable target on a CT-scan available for external review, with at least one diameter > or = 2 cm, in a non-irradiated area
•- Adequate cardiac function (LVEF > or = 50%)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Prior therapy for advanced disease. Adjuvant or Neoadjuvant therapy or chemo-radiotherapy for primary local disease are permitted if at least 6 months have elapsed
•- Congestive heart failure (NYHA class II, III, IV) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, poorly controlled hypertension (systolic >180 mmHg or diastolic >100 mmHg), clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias
•- Patients with dyspnoea at rest due to malignant or other disease or who require supportive oxygen therapy

发起方

ACROSS Group