Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma (N08CPA)
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|ClinicalTrials.gov Identifier: NCT01211275|
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Biological: axitinib Drug: chemotherapy||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 22, 2009|
|Actual Primary Completion Date :||November 13, 2012|
|Actual Study Completion Date :||May 6, 2013|
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 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211275
|Antoni van Leeuwenhoekziekenhuis (NKI-AVL)|
|Amsterdam, Noord-Holland, Netherlands, 1066 CX|
|Principal Investigator:||P Baas, Dr.||NKI-AvL|