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Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain

Primary Purpose

Kidney Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sorafenib tosylate
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring tumors metastatic to brain, recurrent renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed renal cell carcinoma metastatic to the brain 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) PATIENT CHARACTERISTICS: 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 following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: 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 recovered 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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Decatur Memorial Hospital Cancer Care Institute
  • Evanston Northwestern Health Care - Evanston Hospital
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
  • Cardinal Bernardin Cancer Center at Loyola University Medical Center
  • Oncology Hematology Associates of Central Illinois, PC - Peoria
  • Central Illinois Hematology Oncology Center
  • Fort Wayne Medical Oncology and Hematology
  • CCOP - Northern Indiana CR Consortium
  • Oncology Care Associates, PLLC
  • David C. Pratt Cancer Center at St. John's Mercy
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate by RECIST radiologic measurements every 8 weeks

Secondary Outcome Measures

Safety by Common Toxicity Criteria version 3.0 every 4 weeks

Full Information

First Posted
March 9, 2006
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00301847
Brief Title
Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain
Official Title
A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial is studying how well sorafenib works in treating patients with kidney cancer that has spread to the brain. 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.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the partial and minor response rate in patients with renal cell carcinoma (RCC) metastatic to the brain treated with sorafenib. SECONDARY OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer, Metastatic Cancer
Keywords
tumors metastatic to brain, recurrent renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sorafenib tosylate
Primary Outcome Measure Information:
Title
Response rate by RECIST radiologic measurements every 8 weeks
Secondary Outcome Measure Information:
Title
Safety by Common Toxicity Criteria version 3.0 every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed renal cell carcinoma metastatic to the brain 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) PATIENT CHARACTERISTICS: 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 following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: 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 recovered 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter M. Stadler, MD, FACP
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Evanston Northwestern Health Care - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201-1781
Country
United States
Facility Name
Ingalls Cancer Care Center at Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Oncology Care Associates, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain

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