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

NCT00301847 | Completed Phase 2

• 4 other identifiers: NCI-2012-02689UCCRC-14227NCI-7296CDR0000462558
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 12

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.

Conditions

Kidney Cancer; Metastatic Cancer

Keywords

tumors metastatic to brain; recurrent renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Response rate by RECIST radiologic measurements every 8 weeks

Secondary Outcomes (1)

• Safety by Common Toxicity Criteria version 3.0 every 4 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

sorafenib tosylate DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (12)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615-7828, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Oncology Care Associates, PLLC

Saint Joseph, Michigan, 49085, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Walter M. Stadler, MD, FACP

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: November 1, 2005
• Primary Completion: June 1, 2007
• Last Updated: February 11, 2013

Record last verified: 2006-04

Locations

US (12)