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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301847
• Other study ID #: NCI-2012-02689
• Secondary ID: UCCRC-14227NCI-7
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2006
• Last updated: February 8, 2013
• Start date: November 2005

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Drug:
• sorafenib tosylate

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Evanston Northwestern Health Care - Evanston Hospital	Evanston	Illinois
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois
United States	Oncology Care Associates, PLLC	Saint Joseph	Michigan
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Central Illinois Hematology Oncology Center	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate by RECIST radiologic measurements every 8 weeks			No
Secondary	Safety by Common Toxicity Criteria version 3.0 every 4 weeks			Yes