PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
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.
Checked against the public recordLast updated Jul 1, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: PTK787/ZK 222584
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Northeast Alabama Regional Medical CenterAnniston, Alabama
- Veterans Affairs Medical Center - BirminghamBirmingham, Alabama
- Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California
- Naval Medical Center - San DiegoSan Diego, California
- Veterans Affairs Medical Center - San DiegoSan Diego, California
- UCSF Comprehensive Cancer CenterSan Francisco, California
- Veterans Affairs Medical Center - San FranciscoSan Francisco, California
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Lombardi Cancer Center at Georgetown University Medical CenterWashington D.C., District of Columbia
- Walter Reed Army Medical CenterWashington D.C., District of Columbia
- Veterans Affairs Medical Center - Washington, DCWashington D.C., District of Columbia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2016. Always confirm current availability with the study team.