CompletedPhase 2NCT00053885

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

StatusCompleted
PhasePhase 2
U.S. locations80
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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