Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma (CVH-CT02)

This is an interventional treatment trial for Recurrent Bladder Cancer focused on measuring Urothelial carcinoma, Trastuzumab, Treatment Read More

Inclusion Criteria:

• Transitional cell carcinoma of the urothelium or bladder histologically proven stage IV AJCC [locally advanced (T4b and / or N + M0) unresectable or metastatic (M1)]
• Tumor and / or metastasis overexpressing HER2 immunohistochemistry (IHC 3 +) or IHC 2 + and FISH +. Centralized analysis.
• Measurable disease with at least one lesion with a diameter> 2 cm for conventional methods (clinical examination, CT or MRI) or> 1 cm for the helical scanner. In case of single metastasis, metastatic disease should be histologically proven
• Age ≥ 18 years and ≤80 years
• Life expectancy> 3 months,
• Index performance status <2 according to ECOG PS,
• No prior chemotherapy other than adjuvant and / or neoadjuvant chemotherapy, without Herceptin ® and complete for more than 6 months (naive to any previous chemotherapy in the metastatic setting)
• No radiotherapy within 4 weeks prior to inclusion,
• Normal cardiac function as measured by ejection fraction (LVEF> 50%),
• Blood and liver satisfactory constants:

Hematological criteria: - Neutrophils> 1.5 x 109 / L, - Chips> 100 x 109 / L - Hemoglobin> 10 g / dL, Liver function: - Alkaline phosphatase (unless bone metastases) <2 x N - Total bilirubin <1.5 x N - transaminases (AST, ALT) <1.5 x N, renal Constants: - Creatinine clearance > 30 ml / min (Cockcroft and Gault, cf. Annex XV protocol)

- Patient's written consent after full information.

Exclusion Criteria:

• Concurrent treatment with an experimental drug, participation in another clinical trial within <30 days
• Patients previously treated with Herceptin ®, or another treatment targeting growth factors EGF (eg Iressa ®, Tarceva ®)
• Existence of a severe pulmonary disease, liver or kidney is likely to be exacerbated by the treatment,
• Other medical conditions: congestive heart failure or angina pectoris even if medically controlled failure, history of myocardial infarction before entering the trial, hypertension or uncontrolled arrhythmias, significant valvular disease,
• Patient with dyspnoea at rest or requiring oxygen therapy or with respiratory failure,
• Presence of a severe infection requiring antibiotics,
• Presence of CNS metastases or meningeal
• History of another malignancy uncured or cured for less than 5 years (except basal cell carcinoma, papillary thyroid carcinoma in situ of the cervix treated)
• Pregnant or lactating or not using effective contraception Women,
• For Cisplatin only: carrying a serious neurological disease, current events devices> NCI grade 2 neuropathy, hearing loss, creatinine clearance <60 ml / min, the patient can not support a patient hydration.