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
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
Actual Study Start Date : | May 22, 2009 |
Actual Primary Completion Date : | November 13, 2012 |
Actual Study Completion Date : | May 6, 2013 |

Arm | Intervention/treatment |
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Experimental: arm 2
axitinib + cisplatin + premetrexed
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Biological: axitinib
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.
Other Names:
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Active Comparator: arm 1
cisplatin + premetrexed
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Drug: chemotherapy
cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
Other Names:
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histologically or cytologically diagnosed malignant mesothelioma
- age > 18 years
- Medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy)
- Measurable or evaluable disease is not required
- Ability to understand the study and give signed informed consent including the approval to accept a second thoracoscopic or surgical treatment after the third course
- No previous chemotherapy
- Radiotherapy is allowed when this is given for palliation, the interval is > 4 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field.
- WHO performance status =< 2
- Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry:
Hematology:
- ANC=>1.5 x 109/L,
- Platelets=>150 x 109/L,
- Hemoglobin => 6,0 mmol/l
Chemistry:
- total serum bilirubin < UNL;
- AST and ALT= < 2.5xUNL,
- AP < 5xUNL (unless bone metastases are present in the absence or any liver disease)
- Serum creatinine =< 2xUNL
Exclusion Criteria:
- Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency
- Previous successful pleurodesis
- Uncontrolled hypertension
- Symptomatic peripheral neuropathy => grade 2 according to NCIC CTC,version 3.0
- Presence of symptomatic CNS metastases
- Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition
- Concomitant administration to any other experimental drugs under investigation
- Impaired renal function

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
Netherlands | |
Antoni van Leeuwenhoekziekenhuis (NKI-AVL) | |
Amsterdam, Noord-Holland, Netherlands, 1066 CX |
Principal Investigator: | P Baas, Dr. | NKI-AvL |
Responsible Party: | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier: | NCT01211275 |
Other Study ID Numbers: |
NL25655.031.08 |
First Posted: | September 29, 2010 Key Record Dates |
Last Update Posted: | February 28, 2017 |
Last Verified: | February 2017 |
mesothelioma chemotherapy translational research axitinib |
Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms |
Lung Diseases Respiratory Tract Diseases Cisplatin Pemetrexed Axitinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |