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A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain

Phase 2
18 Years
Not Enrolling
Kidney Cancer, Metastatic Cancer

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Trial Information

A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain


I. Determine the partial and minor response rate in patients with renal cell carcinoma (RCC)
metastatic to the brain treated with sorafenib.


I. Determine the toxicity of sorafenib in patients with RCC metastatic to the brain.

II. Determine whether the effect of sorafenib on RCC metastatic to the brain is similar to
its effect on non-brain metastatic sites.

OUTLINE: This is a multicenter study.

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

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


- Histologically or cytologically confirmed renal cell carcinoma metastatic to the

- Measurable disease in the brain

- Meets 1 of the following criteria:

- No prior brain-specific therapy AND no CNS symptoms referable to the brain
lesion(s) (with or without concurrent steroid therapy)

- CNS symptoms referable to the brain lesion(s) AND received primary therapy for
the brain lesion(s)


- Blood pressure < 140/90 mm Hg on 2 separate occasions, taken at least 24 hours apart,
within the past 6 weeks (patients on stable anti-hypertensive regimens allowed)

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- Bilirubin < 1.5 times upper limit of normal (ULN)

- ALT/AST < 2.5 times ULN

- Estimated glomerular filtration rate > 30 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to swallow pills or comply with an oral treatment regimen

- No history of a bleeding diathesis or requirement for full-dose anticoagulation

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to sorafenib

- No clinical or radiologic evidence of bowel obstruction or perforation

- No other uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study


- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
and recovered

- More than 4 weeks since prior radiotherapy to sites outside of the brain and

- More than 8 weeks since prior standard external-beam radiotherapy to the brain unless
there is evidence of in-brain progression

- No prior complete surgical resection or radiosurgery of all known brain metastases
unless there is evidence of in-brain progression

- No prior sorafenib, sunitinib malate, bevacizumab, or any other agent targeting the
platelet-derived growth factor receptor (PDGFR) or vascular endothelial growth factor
receptor (VEGFR) kinase cascade

- No other concurrent investigational agents

- No concurrent enzyme-inducing anti-seizure medications, including phenytoin,
phenobarbital, carbamazepine, or primidone

- Concurrent non-enzyme-inducing anti-seizure medications allowed

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent hematopoietic growth factors except erythropoietin

- No concurrent ketoconazole, itraconazole, or ritonavir

- No concurrent grapefruit juice

- No concurrent Hypericum perforatum (St. John's wort)

- No concurrent chemotherapy

- No concurrent hormonal therapy except steroids for adrenal failure and/or control of
CNS edema or hormones for non-disease related conditions (e.g., insulin for diabetes)

- No concurrent palliative radiotherapy

- No other concurrent anticancer therapy

- Concurrent bisphosphonates allowed

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate by RECIST radiologic measurements every 8 weeks

Safety Issue:


Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

Related Keywords:

  • Kidney Cancer
  • Metastatic Cancer
  • tumors metastatic to brain
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
University of Chicago Cancer Research Center Chicago, Illinois  60637
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Evanston Northwestern Health Care - Evanston Hospital Evanston, Illinois  60201
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Central Illinois Hematology Oncology Center Springfield, Illinois  62701
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey, Illinois  60426
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
Fort Wayne Medical Oncology and Hematology Fort Wayne, Indiana  46815
Oncology Care Associates, PLLC Saint Joseph, Michigan  49085