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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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:

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

SECONDARY OBJECTIVES:

  1. 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.

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 groups in NCT00301847
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.

  1. Response rate by RECIST radiologic measurements every 8 weeks

Secondary outcomes (1)
  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.

  1. First posted13 Mar 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2007

Resources

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)
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

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.

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