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Mesothelioma Clinical Trials

PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

This study is currently recruiting patients.

Sponsored by

Cancer and Leukemia Group B
For more information:National Cancer Institute (NCI)

RATIONALE: PTK787/ZK 222584 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of PTK787/ZK 222584 in treating patients with unresectablemalignant mesothelioma.

Condition Treatment or Intervention
advanced malignant mesothelioma
epithelial mesothelioma
recurrent malignant mesothelioma
sarcomatous mesothelioma
Drug: PTK787/ZK 222584
Procedure: anti-cytokine therapy
Procedure: antiangiogenesis therapy
Procedure: biological response modifier therapy
Procedure: enzyme inhibitor therapy
Procedure: growth factor antagonist therapy
Procedure: protein tyrosine kinase inhibitor therapy

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of PTK787/ZK 222584 in Patients With Unresectable Malignant Mesothelioma

Further Study Details: 


  • Determine the efficacy of PTK787/ZK 222584, in terms of 3-month progression-free survival, in patients with malignant mesothelioma.
  • Determine the response rate in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine the overall and failure-free survival of patients treated with this drug.
  • Correlate pretreatment circulating serum levels of vascular endothelial growth factor (VEGF), platelet-derived growth factor, and VEGF mRNA isoforms with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral PTK787/ZK 222584 daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed 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 40 patients will be accrued for this study within 9-13 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histologically confirmed malignant mesothelioma of 1 of the following types:
  • Epithelial
  • Sarcomatoid
  • Mixed
  • Not amenable to radiotherapy or curative surgery
  • Any site of origin including, but not limited to, the following:
  • Pleura
  • Peritoneum
  • Pericardium
  • Tunica vaginalis
  • At least one unidimensionally measurable lesion outside of prior irradiation port
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • The following are not considered measurable:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • No known brain metastases  

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