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Phase 2 N=49 Treatment

Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

Kidney Cancer

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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