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Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00107432
First Posted: April 6, 2005
Last Update Posted: June 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
This phase II trial is studying how well sorafenib works in treating patients with malignant mesothelioma. 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.

Condition Intervention Phase
Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma Stage IA Malignant Mesothelioma Stage IB Malignant Mesothelioma Stage II Malignant Mesothelioma Stage III Malignant Mesothelioma Stage IV Malignant Mesothelioma Drug: sorafenib tosylate Other: laboratory biomarker analysis Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of BAY 43-9006 (NSC #724772) in Patients With Malignant Mesothelioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (including complete and partial response) [ Time Frame: Up to 3 years ]
    The frequency of best response to the new treatment will be tabulated and the exact 95% binomial confidence intervals will be computed.


Secondary Outcome Measures:
  • Time to tumor progression [ Time Frame: Up to 3 years ]
    Described using the Kaplan Meier method.

  • Percentage of patients remaining failure-free [ Time Frame: At 3 months ]
    Described using the Kaplan-Meier method.

  • Overall survival [ Time Frame: Up to 3 year ]
    Described using the Kaplan-Meier method.


Enrollment: 44
Study Start Date: October 2004
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (sorafenib tosylate)
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
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the response rate (partial response (PR) and complete response (CR)) in patients with malignant mesothelioma treated with BAY 43-9006.

SECONDARY OBJECTIVES:

I. To determine 3-month failure free survival in patients with malignant mesothelioma treated with BAY 43-9006.

II. To describe the median and overall survival of malignant mesothelioma patients treated with BAY 43-9006.

III. To describe the toxicity profile of BAY 43-9006 in patients with malignant mesothelioma.

IV. To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf gene and correlate these findings with anti-tumor activity of BAY 43-9006.

V. To determine whether the amount of expression of phospho-ERK1/2, as determined by immunohistochemistry from pre-treatment tumor specimens, correlates with anti-tumor activity of BAY 43-9006 in patients with mesothelioma.

VI. To determine whether baseline levels and changes following BAY 43-9006 treatment in angiogenic cytokines (VEGF and PDGF) correlate with anti-tumor activity of BAY 43-9006.

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 at least every 2 months for 1 year, every 4 months for 1 year, and then every 6 months for 1 year.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented malignant mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to curative surgery; any site of origin of malignant mesothelioma, including but not limited to: pleura, peritoneum, pericardium and tunica vaginalis is allowed
  • Pathology blocks or slides from a core surgical biopsy must be available for evaluation of ERK 1/2 phosphorylation by immunohistochemistry and for sequencing of B-raf exons 11 and 15
  • Chemotherapy naive or no more than one pemetrexed containing chemotherapy regimen; chemotherapy may have been pemetrexed alone or in combination with any other agent
  • No prior tyrosine kinase/signal transduction/angiogenesis inhibitor therapy
  • Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy
  • >= 3 weeks since major surgery
  • >= 4 weeks since completion of prior radiation therapy, as long as measurable disease lies outside of the radiation port
  • >= 4 weeks since the completion of prior pemetrexed-containing chemotherapy
  • No treatment with an investigational agent currently or within the last 28 days
  • No patients with known brain metastases; patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Patients with pleural rind only disease must have at least one level with one rind measurement >= 1.5 cm
  • Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (CT, MRI, x-ray) or as >= 10 mm with spiral CT scan
  • ECOG Performance status of 0-1
  • No prior history of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006
  • Non-pregnant and non-nursing because the effects of BAY 43-9006 on the fetus/infant are unknown; in addition, women of child-bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
  • Patients with a "currently active" second malignancy other than non melanoma skin cancers and carcinoma in situ of the cervix are not eligible; patients are not considered to have a "currently active" second malignancy if they have completed therapy and are considered to have a less than 30% chance of risk of relapse
  • No patients with uncontrolled intercurrent illness including but not limited to: ongoing active infections, symptomatic congestive heart failure, unstable angina pectoris, hypertension, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No patients on therapeutic anticoagulation; prophylactic anticoagulation (i.e., low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for INR are met
  • No evidence of bleeding diathesis
  • No HIV positive patients receiving combination anti-retroviral therapy; patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006
  • Granulocytes >= 1,500/ul
  • Platelet count >= 100,000/μl
  • Total Bilirubin =< 1.5 x ULN
  • AST (SGOT) =< 2.5 x ULN
  • Creatinine or Creatinine Clearance =< 1.5 x ULN >= 60 ml/minute
  • INR < 1.5
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107432


Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Pasi Janne Cancer and Leukemia Group B
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00107432     History of Changes
Other Study ID Numbers: NCI-2012-02813
CALGB-30307
CDR0000415372
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: April 5, 2005
First Posted: April 6, 2005
Last Update Posted: June 5, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Mesothelioma
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Sorafenib
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs