Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	CALGB-30107 NCT00053885

Objectives

1. Determine the efficacy of PTK787/ZK 222584, in terms of 3-month progression-free survival, in patients with malignant mesothelioma.
2. Determine the response rate in patients treated with this drug.
3. Determine the toxicity of this drug in these patients.
4. Determine the overall and failure-free survival of patients treated with this drug.
5. 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.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

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

Chemotherapy

• 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)

Radiotherapy

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

Surgery

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

Other

• 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

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

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

Renal

• 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

Cardiovascular

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

Other

• 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

Expected Enrollment

A total of 40 patients will be accrued for this study within 9-13 months.

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.

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Thierry Jahan, MD, Protocol chair		Ph: 415-353-7065; 800-888-8664

Registry Information
Official Title		A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients with Unresectable Malignant Mesothelioma
Trial Start Date		2003-07-15
Registered in ClinicalTrials.gov		NCT00053885
Date Submitted to PDQ		2002-12-06
Information Last Verified		2006-10-05
NCI Grant/Contract Number		CA31946

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