Metastatic Renal Cell CarcinomaPhase 2SERCCNCT01342627
Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study testing Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65 years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Nephrectomized, metastatic Clear Cell RCC patients not suitable for cytokines or anti-angiogenesis (bevacizumab or sunitinib) therapy as first line treatment
- Age ≥ 65years
- ECOG Performance Status of ≤ 2
- MSKCC prognostic score, good or intermediate
- Life expectancy of at least 12 weeks.
- Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT/MRI-scan.
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- 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.
- Ability to take correctly oral drugs.
- 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.
- Written Informed Consent
- 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.
Who cannot join
- Previous first line treatment for mRCC. No adjuvant or neoadjuvant treatments are allowed.
- 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)
- 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.
- 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
- Active clinically serious infections (≥ grade 2 NCI-CTC version 3.0)
- Patients undergoing renal dialysis
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- 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.
- Patients with evidence or history of bleeding diathesis
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- Known allergy to sorafenib or one of its constituents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma (SERCC Study) Impact of Adverse Events Management in Elderly mRCC Patients Treated With Sorafenib
Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65 years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib.
Each patient treated with sorafenib enrolled in the study will be trained to observe the management tool for skin care. A study period of 3 years was estimated as follows: an enrollment period of 24 months and a further follow-up period of 12 months.
Read more
Objectives of the trial Primary objective The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of Hand-Foot Skin Reaction (HFSR).
Secondary Objectives
TO assess:
- 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
Read the detailed description
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 discontinued.
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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Sorafenib
- Keywords
- Renal Carcinoma, Metastatic, Sorafenib, Elderly
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
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 protocol.
In case of disease progression Sorafenib administration will be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Experimental | 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 protocol.
In case of disease progression Sorafenib administration will be discontinued. Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of HFSR
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.
Measured: From enrollment in the study until 1 year
Secondary outcomes (4)
Frequency of dose discontinuation, interruption and reduction
Frequency of dose discontinuation, interruption and reduction
Measured: From enrollment in the study until 1 year
Incidence of any grade diarrhoea, and other adverse events
Incidence of any grade diarrhoea, and other adverse events
Measured: From enrollment in the study until 1 year
Overall Response Rate
Overall Response Rate according to the RECIST criteria
Measured: From enrollment in the study until 1 year
Progression free survival (PFR)
Progression free survival (PFR) in study population and comparison of Progression Free Survival (PFS) between age sub groups in the current study population
Measured: From enrollment in the study until 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2014
- Study completionSep 2015
Why it stopped: low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Fratino, oncologist, Principal investigator, Centro di Riferimento Oncologico - IRCCS - Aviano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342627
- Sponsor's protocol ID
- 2010-019726-14
- Acronym
- SERCC
- Status last verified
- Oct 2015
- First submitted
- 29 Nov 2010
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma (SERCC Study) Impact of Adverse Events Management in Elderly mRCC Patients Treated With Sorafenib
- ClinicalTrials.gov ID
- NCT01342627
- Acronym / sponsor ID
- SERCC / 2010-019726-14
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Renal Carcinoma, Metastatic, Sorafenib, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65 years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib.
Each patient treated with sorafenib enrolled in the study will be trained to observe the management tool for skin care. A study period of 3 years was estimated as follows: an enrollment period of 24 months and a further follow-up period of 12 months.
Objectives of the trial Primary objective The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of Hand-Foot Skin Reaction (HFSR).
Secondary Objectives
TO assess:
- 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
Detailed description
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 discontinued.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: SorafenibSorafenib 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 protocol. In case of disease progression Sorafenib administration will be discontinued. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (19 listed)
- Nephrectomized, metastatic Clear Cell RCC patients not suitable for cytokines or anti-angiogenesis (bevacizumab or sunitinib) therapy as first line treatment
- Age ≥ 65years
- ECOG Performance Status of ≤ 2
- MSKCC prognostic score, good or intermediate
- Life expectancy of at least 12 weeks.
Key exclusion criteria (11 listed)
- Previous first line treatment for mRCC. No adjuvant or neoadjuvant treatments are allowed.
- 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)
- 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.
- 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
- Active clinically serious infections (≥ grade 2 NCI-CTC version 3.0)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibAlso: NexavarSorafenib 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 protocol. In case of disease progression Sorafenib administration will be discontinued. | Drug | Sorafenib |
Primary outcome
The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of HFSR
Time frame: From enrollment in the study until 1 year
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.
4 secondary outcomes
Frequency of dose discontinuation, interruption and reduction
Time frame: From enrollment in the study until 1 year
Incidence of any grade diarrhoea, and other adverse events
Time frame: From enrollment in the study until 1 year
Overall Response Rate
Time frame: From enrollment in the study until 1 year
Progression free survival (PFR)
Time frame: From enrollment in the study until 1 year
Results and safety
The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- web site of Centro di Riferimento Oncologico (sponsor and coordinator center)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Fratino, oncologist principal investigator
Centro di Riferimento Oncologico - IRCCS - Aviano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of HFSR (time frame: From enrollment in the study until 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.