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Axitinib in Malignant Mesothelioma (N08CPA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by The Netherlands Cancer Institute.
Recruitment status was:  Recruiting
Information provided by:
The Netherlands Cancer Institute Identifier:
First received: September 27, 2010
Last updated: September 28, 2010
Last verified: September 2010
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

Condition Intervention Phase
Malignant Pleural Mesothelioma
Biological: axitinib
Drug: chemotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • the side effects of the standard chemotherapy and the additional risks related to axitinib use [ Time Frame: AE;SAE;SUSAR ]
    hypertension, fatigue, abdominal discomfort

Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 2
axitinib + cisplatin + premetrexed
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:
  • cisplatin
  • alimta
Active Comparator: arm 1
cisplatin + premetrexed
Drug: chemotherapy
cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
Other Names:
  • cisplatin
  • alimta

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:


  • ANC=>1.5 x 109/L,
  • Platelets=>150 x 109/L,
  • Hemoglobin => 6,0 mmol/l


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01211275

Contact: P. Baas, Dr. +31 (0)20-5122958
Contact: W. A. Buikhuisen, MD +31 (0)20-5122958

Antoni van Leeuwenhoekziekenhuis (NKI-AVL) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Contact: P Baas, Dr.    +31 (0)20-5122958   
Contact: W. A. Buikhuisen, MD    +31 (0)20-5122958   
Principal Investigator: P Baas, Dr.         
Sponsors and Collaborators
The Netherlands Cancer Institute
Principal Investigator: P Baas, Dr. NKI-AvL
  More Information

Responsible Party: Dr. P. Baas, Netherlands Cancer Institute/Antoni van Leeuwenhoekziekenhuis (NKI-AVL) Identifier: NCT01211275     History of Changes
Other Study ID Numbers: NL25655.031.08 
Study First Received: September 27, 2010
Last Updated: September 28, 2010

Keywords provided by The Netherlands Cancer Institute:
translational research

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors processed this record on February 23, 2017