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Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

Brief Summary

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

Tracking Information
First Received DateSeptember 27, 2010
Last Changed DateFebruary 27, 2017
Start DateMay 22, 2009
Actual Primary Completion DateNovember 13, 2012
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]

Secondary Outcome Measures

the side effects of the standard chemotherapy and the additional risks related to axitinib use [Time Frame: AE;SAE;SUSAR]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
Intervention
  • Biological: axitinib
  • Drug: chemotherapy
Study Arms / Comparison Groups2 / 0
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.

Recruitment Information
Recruitment StatusCompleted
Actual Enrollment32
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
NCTIDNCT01211275
Responsible Party,
SponsorThe Netherlands Cancer Institute
Verification DateFebruary 2017
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