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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples
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
micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis
No
P Baas, Dr.
Principal Investigator
NKI-AvL
The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
NL25655.031.08
NCT01211275
May 2009
September 2010
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