PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

This study has been completed.
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology Identifier:
First received: February 5, 2003
Last updated: September 28, 2013
Last verified: September 2013

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 unresectable malignant mesothelioma.

Condition Intervention Phase
Malignant Mesothelioma
Drug: vatalanib
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma

Resource links provided by NLM:

Further study details as provided by Alliance for Clinical Trials in Oncology:

Enrollment: 47
Study Start Date: July 2003
Study Completion Date: June 2006
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 times ULN
  • Negative for proteinuria by dipstick OR
  • Urinary protein no greater than 500 mg and creatinine clearance at least 50 mL/min


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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-barrier contraception
  • No currently active second malignancy except non-melanoma skin cancers (unless therapy is completed and risk of relapse is less than 30%)
  • No other concurrent uncontrolled illness
  • No ongoing active infections
  • No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

  • No prior signal transduction inhibitor therapy
  • No prior angiogenesis inhibitor therapy


  • No prior cytotoxic chemotherapy for this malignancy
  • No concurrent chemotherapeutic agents
  • Prior intrapleural cytotoxic or sclerosing therapy (including bleomycin) allowed

Endocrine therapy

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


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


  • See Disease Characteristics
  • At least 2 weeks since prior major surgery


  • At least 30 days since prior investigational agents
  • At least 7 days since prior grapefruit or grapefruit juice
  • At least 7 days since prior CYP3A4 inducers
  • No prior PTK787/ZK 222584
  • No prior tyrosine kinase inhibitor therapy
  • No other concurrent investigational agents
  • No concurrent isoenzyme inducers or inhibitors of p450
  • No concurrent warfarin or similar oral anticoagulants

    • Heparin allowed
  • No concurrent grapefruit or grapefruit juice
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its identifier: NCT00053885

  Show 80 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Study Chair: Thierry Jahan, MD University of California, San Francisco
  More Information

Additional Information:
Jahan TM, Gu L, Wang X, et al.: Vatalanib (V) for patients with previously untreated advanced malignant mesothelioma (MM): A phase II study by the Cancer and Leukemia Group B (CALGB 30107). [Abstract] J Clin Oncol 24 (Suppl 18): A-7081, 2006.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00053885     History of Changes
Other Study ID Numbers: CDR0000269537, U10CA031946, CALGB-30107
Study First Received: February 5, 2003
Last Updated: September 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
advanced malignant mesothelioma
epithelial mesothelioma
recurrent malignant mesothelioma
sarcomatous mesothelioma

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on April 15, 2014