Clinical trial · Interventional
PTK787/ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
A Phase II Study of PTK787/ZK222584 (NSC#719335) in Patients With Unresectable Malignant Mesothelioma
NCT00053885CI-TRIAL-00022805completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTK787/ZK 222584 | Drug | Vatalanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PTK787/ZK 222584
- description
- 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.
- interventionNames
- Drug: PTK787/ZK 222584
Primary outcomes (2)
- measure
- Survival
- timeFrame
- Up to 3 years post-treatment
- measure
- Failure free survival
- timeFrame
- Up to 3 years post-treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 patientsReferences
Publications (2)
- RESULTJahan TM, Gu L, Wang X, et al.: Vatalanib (V) for patients with previously untreated advanced malignant mesothelioma (MM): A phase II study by the Cancer and Leukemia Group B (CALGB 30107). [Abstract] J Clin Oncol 24 (Suppl 18): A-7081, 2006.
- DERIVEDJahan T, Gu L, Kratzke R, Dudek A, Otterson GA, Wang X, Green M, Vokes EE, Kindler HL. Vatalanib in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (CALGB 30107). Lung Cancer. 2012 Jun;76(3):393-6. doi: 10.1016/j.lungcan.2011.11.014. Epub 2011 Dec 22. PMID 22197613