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Basic Trial Information
Summary Primary: To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of sorafenib followed by sunitinib is at least as effective as sunitinib followed by sorafenib Secondary: 1. Time from randomization to progression during second-line therapy (total TTP) 2. Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm 3. PFS in first-line and second-line treatment, descriptively 4. Overall survival, descriptively (data cut-off same as for primary endpoint) 5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria) 6. Cardiotoxicity analysis by means of echocardiography and NT-pro BNP with an interim analysis after 100 patients of each arm have completed the study 7. Safety and tolerability Eligibility Criteria Inclusion Criteria: 1. Patients with metastatic / advanced RCC (all histologies), who are not suitable for cytokine therapy and for whom study medication constitutes first-line therapy 2. Age > 18 years 3. ECOG Performance Status of 0 or 1 4. MSKCC prognostic score, low 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:
8. Written Informed Consent Exclusion Criteria: 1. 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. 2. History of HIV infection or chronic hepatitis B or C 3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 4. 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) 5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) 6. History of organ allograft 7. Patients with evidence or history of bleeding diathesis 8. Patients undergoing renal dialysis 9. 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. 10. 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 3 months after the completion of trial. 11. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results 12. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 13. Patients unable to swallow oral medications 14. Known allergy to sunitinib or sorafenib or one of its constituents Excluded therapies and medications, previous and concomitant: 1. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. 2. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study 3. Autologous bone marrow transplant or stem cell rescue within 4 months of study 4. 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] 5. Investigational drug therapy outside of this trial during or within 4 weeks of study entry 6. Prior exposure to the study drug. 7. Any St. John's wort containing remedy Trial Lead Organizations/Sponsors Sponsor GmbH iOMEDICO AGLink to the current ClinicalTrials.gov record. Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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