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A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy

Phase 2
18 Years
Not Enrolling
Kidney Cancer

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Trial Information

A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma (RCC) Refractory to SU11248 or Bevacizumab Therapy



- 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.

Inclusion Criteria


- Histologically confirmed renal cell carcinoma with a component of clear cell

- 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

- No prior sorafenib tosylate

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- No concurrent prophylactic growth factors

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor Burden Reduction Rate (TBRR)

Outcome Description:

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.

Outcome Time Frame:

at 8 weeks (2cycles of treatment)

Safety Issue:


Principal Investigator

Brian I. Rini, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

December 2009

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195
Baylor Sammons Cancer Center Dallas, Texas  75246