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Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma (SERCC Study) Impact of Adverse Events Management in Elderly mRCC Patients Treated With Sorafenib

Phase 2
65 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma (SERCC Study) Impact of Adverse Events Management in Elderly mRCC Patients Treated With Sorafenib

Rationale of the present study For several decades, the systemic management of metastatic
renal cell cancer (mRCC) was confined to the use of interferon (IFN) and interleukin-2
(IL-2). Recently, options for the medical management of mRCC have been improved through the
introduction of agents targeting tumour angiogenesis or intracellular pathways mediating
growth and proliferation. Among these agents are the small molecule inhibitors sorafenib
(Nexavar), sunitinib (Sutent), temsirolimus (Torisel) and everolimus, and the monoclonal
antibody bevacizumab (Avastin). All these targeted agents have been shown significantly to
extend progression-free or overall survival or both when compared with placebo or IFN
therapy in the treatment of mRCC.

Adverse events are commonly observed in clinical practice by using these small molecule
inhibitors in mRCC patients. Concerning the use of bevacizumab the most commonly observed
adverse events are hypertension, proteinuria, bleeding and thrombosis. For sunitinib the
most frequent adverse events include hand-foot syndrome, stomatitis, diarrhea, fatigue,
hypothyroidism and hypertension.

Most common adverse events with sorafenib are hand foot skin reaction (HFSR) rash,
desquamation, fatigue, diarrhea, nausea, hypothyroidism and hypertension.Several studies and
recommendations have been published in order to suggest how to manage sorafenib adverse
reactions and in particular the HFSR.

The aim of this study is to evaluate if patients education programs for the prevention of
dermatological events (HFSR, rash, desquamation) can reduce the onset these adverse events
(all grades). The reduction of dermatological adverse effects would concomitantly limit the
frequencies of sorafenib dose reduction and interruptions in mRCC patients not suitable for
cytokines or anti-angiogenesis (bevacizumab or sunitinib) therapy as first line treatment.

Treatment Administration Sorafenib will be orally administered at a daily dose of 400 mg
taken twice daily without food, at least one hour before or two hours after eating. Four
weeks of treatments will be considered as a cycle. Each patient enrolled in the study will
received medications for topical therapy. Dermatological medications will be provided free.

In case of toxicities, dose reduction/interruption is permitted according to the flow
charts/dose modifications.

In case of disease progression, or unacceptable toxicities Sorafenib administration will be

The patient will be considered "out of treatment" if Sorafenib intake is stopped for more
than 30 consecutive days and the patient will be considered for survival.

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 ≤ 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:

- Hemoglobin > 9.0 g/dl

- Absolute neutrophil count (ANC) ≥ 1,500/mm3

- Platelet count ≥ 100,000/μl

- Total bilirubin ≤ 1.5 times the upper limit of normal

- ALT and AST ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for
patients with liver involvement of their cancer)

- Alkaline phosphatase ≤ 4 x upper limit of normal

- 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.]

- 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

10. Written Informed Consent

11. To be able to understand medical instruction and to fill in the patient's diary. If
not, check if adequately supported by his/her family.

Exclusion Criteria:

1. Previous first line treatment for mRCC. No adjuvant or neoadjuvant treatments are

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of HFSR

Outcome Description:

The primary aim 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% and fixing error probabilities(alfa=0.05 and beta=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.

Outcome Time Frame:

From enrollment in the study until 1 year

Safety Issue:


Principal Investigator

Lucia Fratino, oncologist

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centro di Riferimento Oncologico - IRCCS - Aviano


Italy: The Italian Medicines Agency

Study ID:




Start Date:

October 2010

Completion Date:

June 2013

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • Renal Carcinoma
  • Metastatic
  • Sorafenib
  • Elderly
  • Carcinoma
  • Carcinoma, Renal Cell