Brief Title
Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma
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
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
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples
Secondary Outcome
the side effects of the standard chemotherapy and the additional risks related to axitinib use
Condition
Malignant Pleural Mesothelioma
Intervention
axitinib
Study Arms / Comparison Groups
arm 2
Description: axitinib + cisplatin + premetrexed
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
32
Start Date
May 22, 2009
Completion Date
May 6, 2013
Primary Completion Date
November 13, 2012
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
P Baas, Dr., ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT01211275
Organization ID
NL25655.031.08
Responsible Party
Sponsor
Study Sponsor
The Netherlands Cancer Institute
Collaborators
Pfizer
Study Sponsor
P Baas, Dr., Principal Investigator, NKI-AvL
Verification Date
February 2017