Advanced irresectable transitional-cell urothelial carcinoma, that includes cancer of the bladder, ureter and renal pelvis
Conditions
Interventions
Trade Name: Trastuzumab (Herceptin)
Product Name: Trastuzumab (Herceptin)
Product Code: 903674
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: TRASTUZUMAB
Concentration unit: mg/ml mill
Sponsors
ACROSS Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy to the combination of Cisplatin, Gemcitabine and Trastuzumab in terms of response rate in patients with advance urothelial carcinoma, that includes the cancer of bladder, of ureter and of renal pelvis with overexpression of C-erbB-2 ;Secondary Objective: To determine the progression-free interval, the duration of the response, the toxicity profile and the overall survival in patients with advance urothelial carcinoma ;Primary end point(s): The principal variable of valoration will be the number of response rates in patientes treated with the combination | — |
Countries
Spain
Outcome results
None listed