Kidney CancerPhase 2NCT00301847
Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain
A Phase 2 study testing sorafenib tosylate in people with Kidney Cancer and Metastatic Cancer, run by National Cancer Institute (NCI) at 12 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Metastatic Cancer
- What is being tested?
- sorafenib tosylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2005to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, 60201-1781
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46885-5099
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615-7828
Oncology Care Associates, PLLC
Saint Joseph, Michigan, 49085
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, 63141
About this study
Official title: A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain
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.
Read the 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.
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.
- Conditions
- Kidney Cancer, Metastatic Cancer
- Being tested
- sorafenib tosylate
- Keywords
- tumors metastatic to brain, recurrent renal cell cancer, stage IV renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Neoplasm Metastasis, Brain Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenib tosylateDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: sorafenib tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate by RECIST radiologic measurements every 8 weeks
Secondary outcomes (1)
Safety by Common Toxicity Criteria version 3.0 every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startNov 2005
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Walter M. Stadler, MD, FACP, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301847
- Sponsor's protocol ID
- NCI-2012-02689
- Other IDs
- UCCRC-14227, NCI-7296, CDR0000462558
- Status last verified
- Apr 2006
- First submitted
- 9 Mar 2006
- Last updated
- 11 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain
- ClinicalTrials.gov ID
- NCT00301847
- Acronym / sponsor ID
- NCI-2012-02689
- Conditions
- Kidney Cancer, Metastatic Cancer
- Keywords
- tumors metastatic to brain, recurrent renal cell cancer, stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2005
- Primary completion
- Jun 2007 (actual)
- First posted
- 13 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: sorafenib tosylatePatients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sorafenib tosylate | Drug | Arm I |
Primary outcome
Response rate by RECIST radiologic measurements every 8 weeks
1 secondary outcome
Safety by Common Toxicity Criteria version 3.0 every 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter M. Stadler, MD, FACP principal investigator
University of Chicago
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sorafenib tosylate in people with Kidney Cancer and Metastatic Cancer, run by National Cancer Institute (NCI) at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate by RECIST radiologic measurements every 8 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.