Mesothelioma Clinical Trials
PTK787/ZK 222584
in Treating Patients With Unresectable Malignant
Mesothelioma
This study is currently
recruiting patients.
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:
OBJECTIVES:
- 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
DISEASE CHARACTERISTICS:
- 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
|