Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma (N08CPA)
|Malignant Pleural Mesothelioma||Biological: axitinib Drug: chemotherapy||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples [ Time Frame: micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis ]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
- the side effects of the standard chemotherapy and the additional risks related to axitinib use [ Time Frame: AE;SAE;SUSAR ]hypertension, fatigue, abdominal discomfort
|Actual Study Start Date:||May 22, 2009|
|Study Completion Date:||May 6, 2013|
|Primary Completion Date:||November 13, 2012 (Final data collection date for primary outcome measure)|
Experimental: arm 2
axitinib + cisplatin + premetrexed
axitinib: 5 mg BID, day 2 until day 21 of each cycle; cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
Active Comparator: arm 1
cisplatin + premetrexed
cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01211275
|Antoni van Leeuwenhoekziekenhuis (NKI-AVL)|
|Amsterdam, Noord-Holland, Netherlands, 1066 CX|
|Principal Investigator:||P Baas, Dr.||NKI-AvL|