A Phase III Randomized Sequential Open-Label Study to Evaluate the Efficacy and Safety of Sorafenib Followed by Sunitinib Versus Sunitinib Followed by Sorafenib in the Treatment of First-Line Advanced / Metastatic Renal Cell Carcinoma
- Conditions
- Renal Cell CarcinomaC65C64Malignant neoplasm of renal pelvisMalignant neoplasm of kidney, except renal pelvis
- Registration Number
- DRKS00003884
- Lead Sponsor
- Sponsor GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 272
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 ans <= 85years
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:
- 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 <= 2 x upper limit of normal.
8. Written Informed Consent
1. History of cardiac disease: congestive heart failure >NYHA class 2 or with LVEF at
baseline echocardiography < 50%; active CAD (MI more than 6 months prior to study
entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta
blockers or digoxin are permitted) or uncontrolled hypertension (defined as blood
pressure >= 160 mmHg systolic and/or >= 90 mmHG diastolic on medication).
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. untreated hypothyrosis
9. Patients undergoing renal dialysis
10. 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.
11. 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.
12. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results
13. Any condition that is unstable or could jeopardize the safety of the patient and
their compliance in the study
14. Patients unable to swallow oral medications
15. 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 duri
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - total Progression Free Survival; time frame: Last patient last visit (LPLV) to October 2013<br>
- Secondary Outcome Measures
Name Time Method - Total Time to Progression; time frame: Last patient last visit (LPLV) to October 2013<br>- Overall survival; time frame: Last patient last visit (LPLV) to October 2013<br>- Disease Control Rate (DCR); time frame: Last patient last visit (LPLV) to October 2013<br>- Cardiotoxicity; time frame: after 100 patients of each arm have completed the study<br>