Histologically proven advanced TCC (transitional cell carcinoma) of the urothelium MedDRA version: 9.1 Level: LLT Classification code 10044420 Term: Transitional cell carcinoma of the bladder stage unspecified
Conditions
Interventions
Trade Name: SUTENT®
Product Name: SUTENT®
Pharmaceutical Form: Capsule*
INN or Proposed INN: sunitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12,5-
Trade
Sponsors
Centre René Huguenin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven advanced transitional cell carcinoma of the urothelium 2. Progressive disease after one line of chemotherapy for locally advanced or metastatic disease 3. Patients treated with neoadjuvant or adjuvant chemotherapy before may be included if the perioperative chemotherapy was performed at least one year before the chemotherapy for metastatic or loco-regional relapse 4. Previous treatment with a platinum derivative 5. Previous chemotherapy or radiotherapy must have been stopped 30 days before first dose of study treatment and patients must have recovered from any serious side effects of treatment 6. Patients must have one measurable lesion defined by RECIST criteria not previously irradiated, assessed by conventional CT-scan ou MRI performed 1.5 x 109/L; Platelets = 100 x 109/L and Hb = 8 g/dL) 10. Adequate hepatic function: total bilirubin = 1.5 times the upper limit of normal (ULN) ASAT and ALAT = 2.5 x ULN or = 5 x UNL in presence of liver metastase 11. Adequate renal function: calculated creatinine clearance = 40 ml/min according to Cockcroft and Gault formula 12. Partial thromboplastin time (PTT) = 1.5 x UNL and INR = 1.5 13. Women and men with reproductive potential must use medically acceptable contraceptive method 14. Patients must be affiliated to a Social Security System 15. Patient Information and written informed consent form signed 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: 1. Previous chemotherapy in an adjuvant or neoadjuvant setting only 2. Prior treatment with radiotherapy involving more than 25 % of marrow producing area 3. Concurrent anti-cancer treatment in an another investigational trial 4. Concurrent anti-cancer treatment 5. Prior treatment on sunitinib 6. Uncontrolled high blood pressure defined as >150/100 mm/Hg despite treatment 7. Progressives brain metastases 8. Any of the following within the 12 months prior to study drug administration: a. myocardial infarction, b. severe/unstable angina pectoris, coronary artery bypass graft, c. symptomatic congestive heart failure, d. cerebrovascular accident, e. including transient ischemic attack, f. pulmonary embolism 9. Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females 10. Ongoing active infection 11. Treatment with anticoagulant agents at therapeutic doses currently or within 2 weeks prior to first day of sunitinib administration. Low molecular weight heparin is allowed. 12. NCI CTC Grade 3 hemorrhage < 4 weeks of starting study treatment 13. History of interstitial pneumonitis or pulmonary fibrosis 14. History of deep venous thrombosis within 6 months prior to entry on study 15. Pre-existing neuropathy of NCI CTCAE grade = 2 16. Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, incidental PT2 prostate cancer found on a radical cystoprostatectomy material; or carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrent disease for 12 months 17. Pregnant women, women who are likely to be pregnant or are breastfeeding 18. Individuals deprived of liberty or placed under the authority of a tutor 19. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and the follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the tumor response rate of sunitinib in patients with advanced or metastatic transitional cell carcinoma of the urothelium which failed or progressed after first line chemotherapy.;Secondary Objective: To evaluate: 1. Safety (NCI CTC) 2. Time to response, duration of response 3. Tumor imaging in contrast-enhanced color Doppler ultrasonography (optional) 4. Progression free survival 5. Overall survival ;Primary end point(s): The determination of antitumor efficacy will be based on objective tumor assessments made according to the Response Evaluation Criteria in Solid Tumors (RECIST) system of unidimensional evaluation (see Appendix 4). | — |
Countries
France
Outcome results
None listed