Clinical trial NCT00301847: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Metastatic Cancer
Keywords: tumors metastatic to brain
recurrent renal cell cancer
stage IV renal cell cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-03-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response rate by RECIST radiologic measurements every 8 weeks
Secondary outcomes:
measure: Safety by Common Toxicity Criteria version 3.0 every 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital Cancer Care Institute
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Health Care - Evanston Hospital
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Care Center at Ingalls Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center at Loyola University Medical Center
state: Illinois
city: Peoria
country: United States
facility: Oncology Hematology Associates of Central Illinois, PC - Peoria
state: Illinois
city: Springfield
country: United States
facility: Central Illinois Hematology Oncology Center
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: Saint Joseph
country: United States
facility: Oncology Care Associates, PLLC
state: Michigan
city: Saint Louis
country: United States
facility: David C. Pratt Cancer Center at St. John's Mercy
state: Missouri
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Chicago
name: Walter M. Stadler, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References: