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Brief Title: Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma
Official Title: A Randomized Phase I/II Study of Standard Chemotherapy (Cisplatin and Pemetrexed) With or Without Axitinib in Patients With Malignant Mesothelioma: Interim Biopsy Analysis to Determine Efficacy
Study ID: NCT01211275
Brief Summary: The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma
Detailed Description: To determine the effects of the addition of axitinib to standard chemotherapy on tissue samples with respect to micro-vessel density (MVD): expression of VEGF-Receptor; PDGF receptor expression; extent of necrosis and apoptosis. To determine the safety of the addition of axitinib (to a maximum of the recommended dose of maximally 2 x 10 mg per day) to the standard treatment with cisplatin and pemetrexed. To determine the feasibility of performing a (second) thoracoscopy after 10 weeks of the combination treatment with cisplatin, pemetrexed and axitinib. Serum samples will be collected and tested for inhibiting effects in a tube formation and spheroid sprouting assay.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Antoni van Leeuwenhoekziekenhuis (NKI-AVL), Amsterdam, Noord-Holland, Netherlands
Name: P Baas, Dr.
Affiliation: NKI-AvL
Role: PRINCIPAL_INVESTIGATOR