A Phase 1/2 interventional study of axitinib and chemotherapy in Malignant Pleural Mesothelioma, sponsored by The Netherlands Cancer Institute. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-28.
Sponsored by The Netherlands Cancer Institute · Phase 1/2, Interventional, and Treatment
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
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.
418 studies on the registry are indexed under Mesothelioma, Malignant; 73 are open to participants now.
This study's enrollment of 32 is below the median of 37 across 336 interventional studies indexed under Mesothelioma, Malignant.
Browse Mesothelioma, Malignant studies →The Netherlands Cancer Institute is the lead sponsor of 230 studies on the registry; 66 are open to participants now.
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Hematology:
Chemistry:
Exclusion Criteria:
axitinib + cisplatin + premetrexed
Biological: axitinib
cisplatin + premetrexed
Drug: chemotherapy
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.
Also known as: cisplatin, alimta
cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
Also known as: cisplatin, alimta
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
Time frame: micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis
the side effects of the standard chemotherapy and the additional risks related to axitinib use
hypertension, fatigue, abdominal discomfort
Time frame: AE;SAE;SUSAR
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Axitinib
The Netherlands Cancer Institute →