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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00301847

Collaborator

(none)

Enrollment

Locations

Arm

3.7

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer Metastatic Cancer	Drug: sorafenib tosylate	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug: sorafenib tosylate

Arm

Intervention/Treatment

Experimental: Arm I

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

Drug: sorafenib tosylate

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
2	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
3	Evanston Northwestern Health Care - Evanston Hospital	Evanston	Illinois	United States	60201-1781
4	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
5	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
6	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615-7828
7	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62701
8	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana	United States	46885-5099
9	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
10	Oncology Care Associates, PLLC	Saint Joseph	Michigan	United States	49085
11	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
12	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226