PATIENTS WITH METASTATIC RENAL CELL CARCINOMA AGED >/= 65 YRS MedDRA version: 9.1 Level: LLT Classification code 10038416
Conditions
Interventions
Trade Name: NEXAVAR*112CPR RIV 200MG
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Nephrectomized, metastatic Clear Cell RCC patients not suitable for cytokines or anti-angiogenesis (bevacizumab or sunitinib) therapy as first line treatment 2. Age = 65years 3. ECOG Performance Status of 0 or 2 4. MSKCC prognostic score, Good or intermediate 5. Life expectancy of at least 12 weeks. 6. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT/MRI-scan. 7. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of therapy: a. Hemoglobin > 9.0 g/dl b. Absolute neutrophil count (ANC) >1,500/mm3 c. Platelet count 100,000/µl d. Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous first line treatment for metastatic RCC. No adjuvant or neoadjuvant treatments are allowed. 2. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) 3. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring antiarrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. 4. History of previous or present seizure disorder requiring medication (such as steroids or anti-epileptics), organ allograft, HIV infection or chronic hepatitis B or C 5. Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 6. Patients undergoing renal dialysis 7. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry. 8. Patients with evidence or history of bleeding diathesis 9. Substance abuse, medical, psychological or social conditions that may interfere with the patient`s participation in the study or evaluation of the study results 10. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 11. Known allergy to sorafenib or one of its constituents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of HFSR.;Secondary Objective: TO asses: • The frequency of dose discontinuation, interruption and reduction • The incidence of any grade diarrhoea, and other adverse events • The overall Response Rate according to the RECIST criteria. • Progression free survival (PFR) in study population and comparison of PFS between age sub groups in the current study population;Primary end point(s): The primary aim of this study is to determine the efficacy of the patient education program in reducing the incidence of HFSR (all grades). The efficacy is measured in terms of percentage of HFSR-free. Simon’s methods will be used to calculate sample size (Simon R, 1989). Considering the optimal two-stage design for phase II, considering a difference p1-p0=20% between patients who undergo education program (p1=60%) and those who do not (p0=40%), and fixing error probabilities (?=0.05 and ?=0.20), the number of patients for the first step is 16. The trial will be terminated if less than 7 HFSR-free patients will be seen. Otherwise the accrual will continue up to a total of 46 patients. | — |
Countries
Italy
Outcome results
None listed