Axitinib in Malignant Mesothelioma (N08CPA)

October 4, 2010

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.

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
- hypertension, fatigue, abdominal discomfort

Eligibility

Criteria

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

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