- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01444807
Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases
A Randomized, Open Label, Multicenter Phase 2 Study, to Evaluate the Efficacy of Sorafenib in Patients With Advanced Renal Cell Carcinoma (RCC) After a Radical Resection of the Metastases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Advanced RCC presents poor prognosis, because its pathogenesis is not clearly understood. However, up-regulation of the Ras pathway is thought to play a role.
VEGF expression could represent independent prognostic factors for survival possibly linking expression of this protein with clinical outcome.
Sorafenib is a potent inhibitor of both Raf-kinase and VEGF R2 signalling The anti-tumoral activity of Sorafenib was clearly demonstrated in phase III trial regarding advanced pretreated RCC.
Surgical removal of metastatic disease could potentially increase the disease control rate.
Particularly in patients with a disease free interval post nephrectomy of at least 1 year, with one small metastatic lesion, metastasectomy could represents an important therapeutic approach.
After a radical resection of the metastatic disease is unclear if an anti-tumoral systemic therapy may increase patient survival.
In summary, both the preclinical and clinical data support further evaluation of Sorafenib in RCC patients.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Alba, Italy
- Cinzia Ortega
-
Aviano, Italy
- Alessandra Bearz
-
Brescia, Italy
- Alfredo Berruti
-
Brindisi, Italy
- Saverio Cinieri
-
Cagliari, Italy
- Francesco Atzori
-
Cremona, Italy
- Rodolfo Passalaqua
-
Firenze, Italy
- Francesco Di Costanzo
-
Lecce, Italy
- Vincenzo Emanuele Chiuri
-
Novara, Italy
- Alessandra Mosca
-
Palermo, Italy
- Vittorio Gebbia
-
Roma, Italy
- Enrico Cortesi
-
Roma, Italy
- Francesco Cognetti
-
San Giovanni Rotondo, Italy
- Franco Morelli
-
-
Mi
-
Milan, Mi, Italy, 20156
- Istituto Tumori Milano
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
- Age ≥ 18 years
- Patients with cytological or histological diagnosis of Renal Cell Carcinoma (RCC)
- Absence of residual lesions following surgical removal of metastatic disease. Assessment must be performed by CT-scan or MRI
- Histologically proven disease free margins of resected surgical specimen
- No more than three months from radical resection on metastases.
- ECOG Performance Status of 0 or 2
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin > 9.0 g/dl
- Absolute neutrophil count (ANC) >1,500/mm3
- Platelet count 100,000/ml
- 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 ULN
- PT-INR/PTT < 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.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care.
- Serum creatinine < 1.5 x upper limit of normal
- Amylase and lipase <1.5 X upper limit of normal
- Signed informed consent must be obtained prior to any study specific procedures
EXCLUSION CRITERIA:
- Prior systemic treatment for metastatic RCC. It is allowed an adjuvant or neoadjuvant therapy before or after nephrectomy if stopped at least 6 months before the resection of metastatic lesion/s.
- History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic).
- History of HIV infection or chronic hepatitis B or C
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- 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. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft
- Patients with evidence or history of bleeding diathesis
- Patients undergoing renal dialysis
- History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
- 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.
- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
- Radiotherapy during study or within 3 weeks of start of study drug.
- Major surgery within 4 weeks of start of study
- Autologous bone marrow transplant or stem cell rescue within 4 months of study
- Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction.) (Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study)
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- Prior exposure to the study drug.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.
- 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
- Patients unable to swallow oral medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sorafenib
Active Arm
|
sorafenib 400 mg bid
Other Names:
|
No Intervention: Best Supportive Care
Comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence Free Survival
Time Frame: December 2011 - December 2014 (3 years)
|
Efficacy of Sorafenib compared with BSC, in RCC patients that have undergone radical resection of recurrent metastatic disease, after prior nephrectomy.
The primary efficacy endpoint is Recurrence Free Survival (RFS),
|
December 2011 - December 2014 (3 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: December 2011 - December 2014 (3 years)
|
December 2011 - December 2014 (3 years)
|
|
Safety Profile
Time Frame: December 2011 - December 2014 (3 years)
|
Physical examination, vital signs, Red blood count: haemoglobin, hematocrit, platelet count, white blood cell count.
WBC should include differential neutrophil, lymphocyte, monocyte, basophil and eosinophil counts.
Electrolyte panel: sodium, potassium, chloride and corrected calcium.Chemistry panel: AST, ALT, bilirubin, alkaline phosphatase, uric acid, total protein, albumin, calcium, lipase, amylase, phosphate, LDH, glucose, creatinine,BUN, and bicarbonate.
Coagulation panel: PT, PT-INR, PTT.
Urinalysis, Adverse event
|
December 2011 - December 2014 (3 years)
|
Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm.
Time Frame: December 2011 - December 2014 (3 years)
|
December 2011 - December 2014 (3 years)
|
Collaborators and Investigators
Investigators
- Study Chair: Giuseppe Procopio, MD, Istituto Tumori Milano
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- GP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Renal Cell Carcinoma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
-
NewLink Genetics CorporationCompletedMetastatic Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Metastatic Kidney Cancer | Refractory Renal Cell Carcinoma | Metastatic Clear-cell Renal CancerUnited States
-
iOMEDICO AGNovartis PharmaceuticalsCompletedCarcinoma, Renal Cell | Clear-cell Metastatic Renal Cell Carcinoma | Locally Advanced and/or Metastatic Renal Cell CarcinomaGermany
-
Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedMetastatic Renal Cell Carcinoma | Metastatic Kidney CancerFrance
-
Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.WithdrawnMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Unresectable Renal Pelvis Urothelial Carcinoma | Unresectable Ureter Urothelial CarcinomaUnited States
-
National Cancer Institute (NCI)RecruitingStage IV Renal Cell Cancer AJCC v8 | Sarcomatoid Renal Cell Carcinoma | Stage IV Bladder Cancer AJCC v8 | Stage IV Urethral Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Bladder Adenocarcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Bladder... and other conditionsUnited States, Puerto Rico
-
Duke UniversityCompletedMetastatic Renal Cell Carcinoma | Metastatic Urothelial Carcinoma | Metastatic Castration-resistant Prostate Cancer (mCRPC)United States
-
Prometheus LaboratoriesCompletedMetastatic Renal Cell Carcinoma | Metastatic MelanomaUnited States
-
Association Pour La Recherche des Thérapeutiques...CompletedClear-cell Metastatic Renal Cell Carcinoma | Clear-cell Renal CarcinomaFrance
Clinical Trials on sorafenib
-
BayerAmgenCompleted
-
Ohio State University Comprehensive Cancer CenterBayerTerminated
-
Technical University of MunichCompleted
-
Ottawa Hospital Research InstituteBayerCompletedMetastatic Colorectal CancerCanada
-
Yiviva Inc.RecruitingAdvanced Hepatocellular CarcinomaUnited States, Taiwan, China, Hong Kong
-
National Cancer Institute (NCI)CompletedNon-Small-Cell Lung CarcinomaUnited States
-
British Columbia Cancer AgencyWithdrawnLocally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)Canada
-
Accelerated Community Oncology Research NetworkBayerTerminatedRenal Cell CarcinomaUnited States
-
China Medical University HospitalUnknown
-
Cancer Institute and Hospital, Chinese Academy...CompletedHepatocellular Carcinoma, Radiotherapy, SorafenibChina