Status:
COMPLETED
Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial Carcinoma
Lead Sponsor:
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Recurrent Bladder Cancer
Stage IV Bladder Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 9 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2010
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01828736
Start Date
February 9 2004
End Date
February 23 2010
Last Update
February 6 2017
Active Locations (15)
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1
Cliniques saint Luc - Université Catholique de Louvain
Brussels, Belgium, 1200
2
CHU de Besançon
Besançon, France, 25000
3
CHU Hôpital Saint André
Bordeaux, France, 33000
4
Hôpital Jean Perrin
Clermont-Ferrand, France, 63000