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PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma

Phase 2
Completed
Conditions
Malignant Mesothelioma
Interventions
Registration Number
NCT00053885
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief 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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
47
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
PTK787/ZK 222584PTK787/ZK 222584Patients 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.
Primary Outcome Measures
NameTimeMethod
SurvivalUp to 3 years post-treatment
Failure free survivalUp to 3 years post-treatment
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (80)

Northeast Alabama Regional Medical Center

🇺🇸

Anniston, Alabama, United States

Veterans Affairs Medical Center - Birmingham

🇺🇸

Birmingham, Alabama, United States

Rebecca and John Moores UCSD Cancer Center

🇺🇸

La Jolla, California, United States

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

Naval Medical Center - San Diego

🇺🇸

San Diego, California, United States

Veterans Affairs Medical Center - San Diego

🇺🇸

San Diego, California, United States

UCSF Comprehensive Cancer Center

🇺🇸

San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco

🇺🇸

San Francisco, California, United States

CCOP - Christiana Care Health Services

🇺🇸

Newark, Delaware, United States

Lombardi Cancer Center at Georgetown University Medical Center

🇺🇸

Washington, District of Columbia, United States

Scroll for more (70 remaining)
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States

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