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Sorafenib in Treating Patients With Malignant Mesothelioma
This study is ongoing, but not recruiting participants.

First Received on April 5, 2005.   Last Updated on March 22, 2011   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00107432
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with malignant mesothelioma.


Condition Intervention Phase
Malignant Mesothelioma
Drug: sorafenib tosylate
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of BAY 43-9006 (NSC #724772, IND #69896) in Patients With Malignant Mesothelioma

Resource links provided by NLM:


Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • Response rate (complete and partial response) [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: October 2004
Estimated Study Completion Date: January 2014
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the partial response and complete response rate in patients with malignant mesothelioma treated with sorafenib.

Secondary

  • Determine the 3-month failure-free survival of patients treated with this drug.
  • Determine the median and overall survival of patients treated with this drug.
  • Determine the toxicity profile of this drug in these patients.
  • Correlate the presence of mutations in exons 11 and 15 of the B-raf gene in tumor tissue with anti-tumor activity of this drug in these patients.
  • Correlate the amount of phospho-ERK1/2 expression in pretreatment tumor tissue with anti-tumor activity of this drug in these patients.
  • Correlate baseline levels of and changes in angiogenic cytokines (vascular endothelial growth factor and platelet-derived growth factor) with anti-tumor activity of this drug in these patients.

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.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 6-8 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant mesothelioma

    • Epithelial, sarcomatoid, or mixed type
    • Any site of origin (e.g., pleura, peritoneum, pericardium, or tunica vaginalis)
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

      • Target lesion must be outside prior radiotherapy port
    • Patients with pleural rind only disease must have ≥ 1 level with 1 rind measuring ≥ 1.5 cm
    • The following are not considered measurable disease:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusions
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
  • Not amenable to curative surgery
  • Must have tissue blocks or slides from a core surgical biopsy available
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 ULN
  • INR < 1.5

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No ongoing, active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other active malignancy except non-melanoma skin cancer, carcinoma in situ of the cervix, or any other completely treated malignancy that has< 30% chance of relapsing
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to study drug
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior angiogenesis inhibitor therapy
  • No concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim

Chemotherapy

  • Prior intrapleural cytotoxic chemotherapy allowed*
  • No more than 1 prior pemetrexed disodium-containing chemotherapy regimen (i.e., pemetrexed disodium alone or in combination with any other agent)
  • At least 4 weeks since prior pemetrexed disodium-containing chemotherapy regimen
  • No concurrent chemotherapy NOTE: *Not considered systemic chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes) or steroids for adrenal failure

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery

  • At least 3 weeks since prior major surgery

Other

  • No prior signal transduction inhibitor therapy
  • No prior protein tyrosine kinase inhibitor therapy
  • Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
  • More than 28 days since prior and no other concurrent investigational agents
  • No concurrent therapeutic anticoagulation therapy with warfarin or heparin derivatives

    • Concurrent prophylactic anticoagulation (e.g., low-dose warfarin) for venous or arterial access devices allowed provided that the requirements for INR are met
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107432

  Show 60 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Pasi Janne, MD, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
Janne PA, Wang XF, Krug LM, et al.: Sorafenib in malignant mesothelioma (MM): a phase II trial of the Cancer and Leukemia Group B (CALGB 30307). [Abstract] J Clin Oncol 25 (Suppl 18): A-7707, 435s, 2007.

Responsible Party: Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00107432     History of Changes
Other Study ID Numbers: CDR0000415372, U10CA031946, CALGB-30307
Study First Received: April 5, 2005
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:
advanced malignant mesothelioma
epithelial mesothelioma
recurrent malignant mesothelioma
sarcomatous mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012