Status:
COMPLETED
Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how we...
Detailed Description
OBJECTIVES: Primary * To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tos...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma with a component of clear cell histology
- Metastatic disease
- Disease progression, as defined by RECIST criteria, after prior treatment with sunitinib malate or bevacizumab
- Patients must have received ≥ 1 course (4 weeks) of sunitinib malate or ≥ 2 doses of bevacizumab AND have RECIST-defined objective progression during or within 4 months after completing treatment with sunitinib malate or bevacizumab
- Measurable disease by RECIST criteria
- CNS metastases allowed provided patient has undergone prior surgery and/or radiotherapy AND has no evidence of further CNS disease progression by CT scan or MRI ≥ 2 weeks after treatment of CNS metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
- WBC ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 75,000/μL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 times ULN
- Negative pregnancy test
- No significant cardiovascular disease, including any of the following:
- Congestive heart failure (New York Heart Association class III-IV heart disease)
- Active angina pectoris requiring nitrate therapy
- Uncontrolled dysrhythmias
- Cardiovascular event within the past 6 months (e.g., transient ischemic attack/cerebrovascular accident, myocardial infarction, or vascular surgery)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 weeks since prior systemic therapy, radiotherapy, or major surgery and recovered
- No prior sorafenib tosylate
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent prophylactic growth factors
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00866320
Start Date
February 1 2006
End Date
December 1 2009
Last Update
July 23 2014
Active Locations (2)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
2
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246