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A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

Thank you

Trial Information

A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thierry Jahan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

June 2006

Related Keywords:

  • Malignant Mesothelioma
  • advanced malignant mesothelioma
  • epithelial mesothelioma
  • recurrent malignant mesothelioma
  • sarcomatous mesothelioma
  • Mesothelioma



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