SORAFENIB IN ELDERLY PATIENTS WITH METASTATIC RENAL CELL CARCINOMA (SERCC STIDY). IMPACT OF ADVERSE EVENTS MANAGEMENT IN ELDERLY mRCC PATIENTS TREATED WITH SORAFENIB. - SERCC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 < 1.5 times the upper limit of normal
e.ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
f.Alkaline phosphatase < 4 x upper limit of normal
g.PT-INR/PT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
h.Serum creatinine < 1.5 x upper limit of normal.

8.Ability to take correctly oral drugs.
9.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
10.Written Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

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

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

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