A phase ii study assesing su-011248 in previously untreated patients with advanced urothelial cancer ineligible for cisplatin-based chemotherapyEstudio fase II que evalúa la eficacia y tolerabilidad de SU-011248 en pacientes previamente no tratados con cáncer uroterial no elegibles para quimioterapia basada en platino
- Conditions
- Previously untreated patients with advanced urothelial cancer ineligible for cisplatin-based chemotherapy
- Registration Number
- EUCTR2005-005115-16-ES
- Lead Sponsor
- Joaquim Bellmunt Molins
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 21
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 < 60 ml/min but higher than 30 mil/min using Crockroft and Gault formula.
3. No prior treatment with chemotherapy is allowed.
4. Measurable or non measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
5. Male or female, 18 years of age or older.
6. ECOG performance status1.
7. Life expectancy greater than 12 weeks.
8. Resolution of all acute toxic effects of prior therapy or surgical procedures to grade lower or equal to 1 (except alopecia).
9. The definitions of minimum adequacy for organ function required prior to study entry are as follows.
•Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) lower or equal to 2.5 x upper limit of normal (ULN), or AST and ALT lower or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
• Total serum bilirubin lower or equal to 1.5 x ULN
• Serum albumin higher or equal to 3.0 g/dL
• Absolute neutrophil count (ANC) higher or equal to 1500/microL
• Platelets higher or equal to 100,000/microL
• Hemoglobin higher or equal to 9.0 g/dL
• Serum creatinine lower or equal to 1.5 x ULN
10. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
11. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
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. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method