Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma

NCT01342627 | Terminated Phase 2

• 1 other identifier: 2010-019726-14
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Renal Carcinoma; Metastatic; Sorafenib; Elderly

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment in the study until 1 year

Secondary Outcomes (4)

• Frequency of dose discontinuation, interruption and reduction

  From enrollment in the study until 1 year

• Incidence of any grade diarrhoea, and other adverse events

  From enrollment in the study until 1 year

• Overall Response Rate

  From enrollment in the study until 1 year

• Progression free survival (PFR)

  From enrollment in the study until 1 year

Study Arms (1)

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.

Drug: Sorafenib

Interventions

Sorafenib DRUG

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.

Also known as: Nexavar

Sorafenib

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico

Aviano, Pordenone, 33081, Italy

Location

Related Links

• web site of Centro di Riferimento Oncologico (sponsor and coordinator center)

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lucia Fratino, oncologist

  Centro di Riferimento Oncologico - IRCCS - Aviano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: April 27, 2011
• Study Start: October 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

IT (1)