Conditions: Non-small Cell Lung Cancer (NSCLC) Lung Cancer Neoplasm Metastasis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 16
Healthy volunteers: no

Brief summary:
This trial evaluated the safety of combining bevacizumab and pemetrexed in non-small cell lung cancer (NSCLC) patients with stable brain metastases as second-line chemotherapy, while evaluating progression-free survival (PFS) and overall survival (OS).

Detailed description:
Brain metastases are a common complication of advanced non-small-cell lung cancer (NSCLC) both at initial presentation and at the time of disease progression. Patients with brain metastases have often been excluded from large randomized phase III trials due to concerns of poorer survival and impaired ability of drugs to cross the blood-brain barrier. However, as survival has improved, some trials have included such patients, often finding similar benefit to patients with metastatic disease elsewhere.

Bevacizumab is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor, has emerged as an important adjunct to platinum-based chemotherapy doublets for use in advanced NSCLC. This drug is normally used as a first line chemotherapy. Pemetrexed is a multi-targeted anti-folate agent,which is approved for use in first-line (with platinum), maintenance, and second-line treatment of advanced nonsquamous NSCLC. Based on the efficacy of pemetrexed as a second line agent and the safety questions surrounding bevacizumab in those with treated brain metastases, a trial was designed to look at the combination of both agents as a second line therapy in NSCLC patients with treated stable brain metastases

Arms:
arm 1: pemetrexed (500 mg/m² IV) + bevacizumab (15 mg/kg IV). In addition to Vitamin B12 + Folate + Dexamethasone

Interventions: intervention 1: Bevacizumab intervention 2: Pemetrexed intervention 3: Vitamin B12 intervention 4: Folate intervention 5: Dexamethasone
Intervention descriptions: intervention 1: 15 mg/kg, IV over 10 minutes every 3 weeks intervention 2: 500 mg/m²; IV over 10 minutes every 3 weeks intervention 3: 1000 micrograms, IM injection 1-2 weeks prior to treatment and repeated every 9 weeks until last dose of pemetrexed intervention 4: 350 to 1000 micrograms 1 week prior to treatment and 3 weeks after last pemetrexed dose intervention 5: 4 mg; oral, twice a day at the following times: the day before, of and after each dose of pemetrexed

Protocol document: