Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

• Status: Completed
• Trial end date: 2013-05-06
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Pfizer
• Treatments: Axitinib; Cisplatin; Pemetrexed

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