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.
|First Received Date||February 5, 2003|
|Last Changed Date||June 30, 2016|
|Start Date||July 2003|
|Actual Primary Completion Date||July 2005|
|Primary Outcome Measures||
Survival [Time Frame: Up to 3 years post-treatment]
Failure free survival [Time Frame: Up to 3 years post-treatment]
|Study Arms / Comparison Groups||1 / 0|
- 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.
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- Histologically confirmed malignant mesothelioma of 1 of the following types:
- Not amenable to radiotherapy or curative surgery
- Any site of origin including, but not limited to, the following:
- 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
- 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
- ECOG 0-1
- 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
PRIOR CONCURRENT 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
- 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
|Sponsor||Alliance for Clinical Trials in Oncology|
|Verification Date||June 2016|