Clinical trial · Interventional
Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma
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
NCT01211275CI-TRIAL-00026187N08CPAcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axitinib | Biological | Axitinib | ALIAS |
| chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- arm 2
- description
- axitinib + cisplatin + premetrexed
- interventionNames
- Biological: axitinib
- type
- ACTIVE_COMPARATOR
- label
- arm 1
- description
- cisplatin + premetrexed
- interventionNames
- Drug: chemotherapy
Primary outcomes (1)
- measure
- To test the impact of the addition of axitinib to standaard chemotherapy treatment on histology samples
- timeFrame
- micro-vessel density;expression of VEGF and PDGF receptor; extent of necrosis and apoptosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.