Previously untreated patients with advanced urothelial cancer ineligible for cisplatin-based chemotherapy
Conditions
Interventions
Product Name: Sunitinib
Product Code: SU-011248
Pharmaceutical Form: Capsule*
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Name: Sunitinib
Product
Sponsors
Joaquim Bellmunt Molins
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven diagnosis of transitional cell carcinoma of the urinary tract with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. Locally recurrent disease must not be amendable to resection or radiation therapy with curative intent. 2. “Unfit” patient defined as Creatinine Clarance =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior chemotherapy regimen or biological treatment for locally advanced or metastatic transitional cell carcinoma of the urinary tract. 2. Prior treatment on a SU011248 clinical trial. 3. Creatinine clearance > 60 ml/min or less than 30 mil/min using Cockroft and Gault formula. 4. Patients included in any dialysis program during selection or if forecast. 5. Prior treatment with any tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors. 6. Major surgery, radiation therapy, or systemic therapy within 3 weeks of study randomization except palliative radiotherapy to non-target metastatic lesions. 7. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 8. Prior radiation therapy to >25% of the bone marrow. 9. Current treatment on another clinical trial. 10. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. 11. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus. 12. Ongoing cardiac dysrhythmias of NCI CTCAE grade higher or equal to 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 13. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 14. Current treatment with therapeutic doses of acenocoumarol. 15. Known human immunodeficiency virus infection. 16. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization. 17. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the time to disease progression (TTP) defined as the time from diagnosis of metastatic urothelial carcinoma until first confirmed progression of the disease and to assess the safety of SU11248 in locally advanced or metastatic trasitional cell carcinoma. Toxicity will be scored based on the NCI common toxicity criteria ;Secondary Objective: To assess the progression-free survival for SU011248 in locally advanced or metastatic transitional cell carcinoma of the urinary tract. To assess overall response rate (ORR) To assess overall survival (OS) Time to treatment failure (TTF) To determine the Pharmacodynamic profile of SU011248 in serum and tumor tissue. IL8, VEGF, MMP9, bFGF, p27, Ki-67 and apoptosis (H/E) are the pharmacodynamic markers that will be analyzed by IHC in each paired pre- and postreatment tumor sample (at week 6 and if possible at time to progression) To determine the Quality of Life in this patients receiving SU011248. Quality of life assessment will be analyzed by questionnaire QLQ-C30 Version 3. ;Primary end point(s): •To determine the time to disease progression (TTP) defined as the time from diagnosis of metastatic urothelial carcinoma until first confirmed progression of the disease and to assess the safety of SU11248 in locally advanced or metastatic trasitional cell carcinoma. Toxicity will be scored based on the NCI common toxicity criteria | — |
Countries
Spain
Outcome results
None listed