Clinical Trial Details

NCT ID: NCT01211275
Date Last Changed: September 28, 2010


Research Study Summary

A Phase 1/Phase 2 clinical study for patients with Malignant Pleural Mesothelioma

Research Study 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


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

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Recruitment Details

Both Male and Female
18 and up
Overall Status
Lead Sponsor
The Netherlands Cancer Institute
16 Months
Facility Type


Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
Netherlands Noord-Holland Amsterdam 1066 CX Antoni van Leeuwenhoekziekenhuis (NKI-AVL)
P Baas, Dr.
+31 (0)20-5122958

P Baas, Dr.
Principal Investigator


P. Baas, Dr.
+31 (0)20-5122958

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