Status:
COMPLETED
Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Pfizer
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 mesotheliom...
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; exten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01211275
Start Date
May 22 2009
End Date
May 6 2013
Last Update
February 28 2017
Active Locations (1)
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1
Antoni van Leeuwenhoekziekenhuis (NKI-AVL)
Amsterdam, North Holland, Netherlands, 1066 CX