Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00866320
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : February 1, 2012
Last Update Posted : July 23, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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 well sorafenib works in treating patients with metastatic kidney cancer that has not responded to sunitinib or bevacizumab.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: sorafenib tosylate Phase 2

Detailed Description:



  • To determine the tumor burden reduction rate in patients with sunitinib malate- or bevacizumab-refractory, metastatic clear cell renal cell carcinoma treated with sorafenib tosylate.


  • To determine the safety of sorafenib tosylate in these patients.
  • To record the duration of tumor reduction, time to disease progression, and overall survival of patients treated with sorafenib tosylate.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy
Study Start Date : February 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: Sorafenib
Chemotherapy single agent systemic. Sorafenib given up to 600mg orally every 12 hours for up to 10 months (40 weeks).
Drug: sorafenib tosylate
Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor targeting both tumor cells and the tumor vasculature. Patients with metastatic RCC meeting eligibility criteria will receive 400 mg BID of sorafenib in a single-arm phase II study. Treatment will be administered on an outpatient basis.

Primary Outcome Measures :
  1. Tumor Burden Reduction Rate (TBRR) [ Time Frame: at 8 weeks (2cycles of treatment) ]
    The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: followed until progression or death for approximately 3 years ]
    Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.

  2. Time to Progression [ Time Frame: followed to progression for approximately 3 years ]

    Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.

    Progression-free survival measured in months and summarized using the Kaplan-Meier method.

  3. Duration of Overall Response (Tumor Burden Reduction) [ Time Frame: followed for overall response for approximately 3 years ]
    Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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)


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00866320

Layout table for location information
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
United States, Texas
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Brian I. Rini, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center Identifier: NCT00866320     History of Changes
Other Study ID Numbers: CASE11805
P30CA043703 ( U.S. NIH Grant/Contract )
CASE11805 ( Other Identifier: Case Comprehensive Cancer Center )
05-167 ( Other Identifier: Cleveland Clinic IRB )
First Posted: March 20, 2009    Key Record Dates
Results First Posted: February 1, 2012
Last Update Posted: July 23, 2014
Last Verified: July 2014
Keywords provided by Case Comprehensive Cancer Center:
clear cell renal cell carcinoma
recurrent renal cell cancer
stage IV renal cell cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Protein Kinase Inhibitors
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action