| General information |
| Database: | DB00922 |
| Objective: | The aim of this open labelphase II study (NCT00407459) was to assess the activity of the vascular endothelial growth factor (VEGF) inhibitor bevacizumab combined with pemetrexed and carboplatin in patients with previously untreated, unresectable malignant pleural mesothelioma (MPM). |
| Authors: | Ceresoli GL, et al |
| Title: | Phase II study of pemetrexed and carboplatin plus bevacizumab as firstline therapy in malignant pleural mesothelioma. |
| Journal: | Br J Cancer. |
| Year: | 2013 |
| PMID: | 23860535 |
| Trial Design |
| Clinical Trial Id: | NCT00407459 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | malignant pleural mesothelioma |
| Cancer Subtype: | malignant pleural mesothelioma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | pemetrexed + carboplatin + bevacizumab |
| Study Type: | Phase II study |
| Key Patients Feature: | patients with previously untreated, unresectable malignant pleural mesothelioma (MPM) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Eligible patients received pemetrexed 500 mg m(2), carboplatin area under the plasma concentrationtime curve (AUC) 5 mg ml(1) per minute and bevacizumab 15 mg kg(1), administered intravenously every 21 days for six cycles, followed by maintenance bevacizumab |
| Primary End Point: | progression free survival (PFS). A 50% improvement in median PFS in comparison with standard pemetrexed/platinum combinations (from 6 to 9 months) was postulated. |
| Secondary End Point: | NA |
| Patients Number: | 76 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 34.20% |
| Disease Control Rate: | 92.10% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.9 months |
| Median OS A vs. C: | 15.3 months |
| Adverse Event(agent arm): | Haematological toxicity was mild and consisted mostly of neutropaenia (Table 2); febrile neutropaenia was observed in two patients. Nonhaematological toxicity was generally mild (Table 2); nausea/vomiting, fatigue, mucositis (stomatitis and conjunctivitis), hypertension and constipation were the most commonly reported adverse effects. Some severe adverse events probably related to bevacizumab were observed, as a grade 3 pulmonary embolism, a severe gastrointestinal bleeding, and three cases of botheyl perforation in three elderly patients (75, 76 and 78 years old, respectively) without evidence of abdominal involvement by disease, or history of major abdominal surgery or comorbidities. however, all these patients had a history of diverticular disease, asymptomatic at enrollment. |
| Conclusions: | The primary end point of the trial was not reached. Hotheyver, due to the limitation of a nonrandomisedphase II design, further data are needed before drawing any definite conclusion on the role of bevacizumab in MPM. |