A multicentre phase II trial to determine the efficacy of the anti-tyrosine kinase sunitinib (SUTENT®) as second line therapy in patients with transitional cell carcinoma (TCC) of the urothelium which failed or progressed after first line chemotherapy for advanced or metastatic disease. - VESS
- Conditions
- Histologically proven advanced TCC (transitional cell carcinoma) of the urotheliumMedDRA version: 9.1Level: LLTClassification code 10044420Term: Transitional cell carcinoma of the bladder stage unspecified
- Registration Number
- EUCTR2008-001004-22-FR
- Lead Sponsor
- Centre René Huguenin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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 < 28 days before first day of study drug administration
7. Patient aged 18 years old or more
8. Patients must have a performance Status < 2 on the Eastern Cooperative Oncology Group Scale
9. Adequate haematological function (ANC > 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1. Safety (NCI CTC)<br>2. Time to response, duration of response<br>3. Tumor imaging in contrast-enhanced color Doppler ultrasonography (optional)<br>4. Progression free survival<br>5. Overall survival<br><br>;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).
- Secondary Outcome Measures
Name Time Method