Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

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

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

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Thierry Jahan

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00053885
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top