I-MVAC +/- Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma Without H-Ras Nor K-Ras Mutations

Exclusion Criteria

• •1. Pure adenocarcinoma or pure epidermoid carcinoma or mixed or pure small-cell neuroendocrine carcinoma
• •2. Previous treatment with one of the following molecules: methotrexate, vinblastine, doxorubicin or Epidermal Growth Factor inhibitor
• •3. History of interstitial pneumonitis or pulmonary fibrosis
• •4. History of cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled serious cardiac arrhythmia) in the year prior to randomisation (≤1 year)
• •5. Ventricular ejection fraction \<50%
• •6. Blood calcium and/or magnesium ≥ grade\* 1
• •7. History of cancer in the 5 years prior to entry in the trial other than basal cell skin cancer or in situ epithelioma of the cervix,
• •8. Treatment with radiotherapy for analgesic purposes (unless treatment was discontinued at least 15 days prior to inclusion in the trial)
• •9. Potential allergy to panitumumab
• •10. Male or female patients not agreeing to use an effective method of contraception throughout the duration of treatment and for 6 months after treatment discontinuation
• •11. Pregnant women, or female subjects liable to become pregnant or currently breast-feeding,
• •12. Patient already included in another therapeutic trial on an investigational medicinal product,
• •13. Persons deprived of their freedom or under judicial protection (including guardianship),
• •14. Unable to receive medical follow-up during the trial owing to geographical, social or psychological reasons.