Phase 2
N=49
Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab
Kidney Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00866320 ↗Enrolled (actual)
49
Serious AEs
8.5%
Results posted
Feb 2012
Primary outcome: Primary: Tumor Burden Reduction Rate (TBRR) — 30; 70 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sorafenib tosylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Burden Reduction Rate (TBRR) |
30; 70 | — |
| SECONDARY Overall Survival |
16 | — |
| SECONDARY Time to Progression |
4.4 | — |
| SECONDARY Duration of Overall Response (Tumor Burden Reduction) |
7.1 | — |
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 well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00866320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.