Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2006-002851-33-AT
EUCTR2006-002851-33-ATActive, not recruitingNot Applicable

Sorafenib and Bevacizumab as first- line treatment in patients with advanced renal cell carcinoma

niv. Prof. Dr. Manuela Schmidinger0 sitesStarted: August 16, 2006Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Age greater or equal to 18 years
  • •Histologically confirmed renal cell carcinoma (primary tumour or biopsy/surgery of metastases)
  • •Radiologically confirmed metastatic disease
  • •Surgically removed primary tumour so feasible (nephrectomy or nephron-sparing surgery as indicated)
  • •ECOG status of 0 or 1
  • •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 14 days prior to treatment start:
  • •oHemoglobin > 9.0 g/L
  • •oLeucocytes greater than or equal to 3000/µL
  • •oAbsolut neutrophil count > or equal 1,500 µL
  • •oPlatelet count above > or equal 100,000 /µL
  • •oTotal bilirubin > or equal 1.5 x upper limit normal
  • •oSerum creatinine < 2.5 x upper limit normal
  • •oALT and AST < 2.5 x upper limit normal (< 5 x upper limit normal for patients with liver involvement of their cancer
  • •oPT or INR and PTT< 1.5 x upper limit normal
  • •Women of childbearing potential and men must agree to use adequate contraception
  • •Signed informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •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

  • •Prior systemic treatment for advanced renal cell carcinoma
  • •Previous or concurrent malignancy 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 and T1) or any cancer curatively treated > 5 years prior to study entry.
  • •Complete renal shut down requiring hemo-or peritoneal dialysis
  • •History of cardiac disease: congestive heart failure > NYHA class 2, active cardiovascular disease (MI less than 6 months prior to study entry), cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers and digoxins are permitted), uncontrolled hypertension or history of poor compliance with antihypertensive treatment
  • •Active clinically serious bacterial or fungal infection (> grade 2 NCI-CTCAE, Version 3)
  • •Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B/C
  • •Evidence of spinal cord compression or brain metastases. A CT or MRI of the brain must be performed within 4 weeks prior to enrolment if the presence of metastases at these sites is suspected.
  • •History or evidence upon physical/neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy e.g. uncontrolled seizures.
  • •Patients with evidence or history of bleeding diathesis, coagulopathy, or thromboembolic event
  • •Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
  • •Known or suspected allergy to any agent given in association with this trial
  • •Any condition that is unstable or which could jeopardize the safety of the patient and his compliance in the study (e.g. uncontrolled diabetes mellitus, pancreatitis, acute or chronic liver disease etc).
  • •Investigational drug therapy outside this trial during or within 4 weeks of the study entry
  • •Prior use of inhibitors of Ras/Raf-, MEK-, AKT kinase- and mTOR-signaling pathway or of Farnesyl transferase inhibitors
  • •Prior use investigational or licensed angiogenesis inhibitors
  • •Concomitant Rifampicin
  • •Significant surgery within 4 weeks prior to study entry
  • •Female patients who are pregnant or breast feeding
  • •Proteinuria defined as a 24-hour urine protein excretion greater than 1000 mg. Urine dipstick proteinuria of 2+ or greater will require a 24 hour urine to determine eligibility for enrollment
  • •Impairment of the gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Sorafenib
  • •Therapeutic anticoagulation with coumadin, heparins or heparinoids
  • •Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (>325 mg/day) or other NSAID
  • •Thrombic or embolic events within the past 6 months
  • •Hypertension defined as systolic blood pressure greater than 140 mm/Hg or diastolic pressure greater than 90 mm/Hg despite optimal management
  • •Serious non-healing wounds, acute or non-healing ulcers, or bone fractures
  • •Evidence of bleeding diathesis
  • •History of hemoptysis or high grade varices
  • •Primary tumor surgically removable
  • •Solitary, surgically removable metastases
  • •Patient unwilling or unable to give informed consent
  • •Pregnancy or breast feeding

Investigators

Sponsor
niv. Prof. Dr. Manuela Schmidinger

Similar Trials

Active, not recruiting
Not Applicable
Sorafenib in the first line treatment of advanced hepatocellular carcinoma with ChildPugh liver function class B. Multicentre phase 3 randomized trial - BOOSTadvanced hepatocellular carcinoma with ChildPugh liver function class BMedDRA version: 9.1Level: LLTClassification code 10024720
EUCTR2009-013870-42-ITISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
Completed
Phase 1
Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI studyon-small cell lung cancer
JPRN-UMIN000015944Okayama Lung Cancer Study Group (OLCSG)24
Active, not recruiting
Not Applicable
Capecitabine and bevacizumab ± vinorelbine as 1st line treatment in HER2/neu-negative metastatic or locally advanced inoperable breast cancer patients
EUCTR2008-003779-37-DEiOMEDICO AG
Completed
Phase 2
Afatinib alone or with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harbouring active EGFR mutations : an open-label, randomized, multicenter, phase II studyon-squamous non-small cell lung cancer
JPRN-UMIN000027432Okayama University100
Terminated
Phase 2
A Phase II Study of Bevacizumab + Sorafenib in Metastatic Breast CancerMetastatic Breast Cancer
NCT00632541Hoosier Cancer Research Network18