drugset / Trial / NCT00870532

Study of Combination of Metronomic Oral Vinorelbine and Sorafenib in Patients With Advanced Non-small Cell Lung Cancer

NCT00870532

Phase 1 Completed 52 enrolled National Cancer Centre, Singapore
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Targeting the blood supply of cancer, called anti-angiogenesis is a new but proven treatment strategy. There are two ways of achieving this effect. The first way to specifically target the molecular pathways that promote new blood vessel formation in cancer. An example of such an agent is sorafenib, which is an oral agent and which is already in use worldwide for the treatment of kidney and liver cancers. The second way is to target the cells lining the blood vessels by using low dose of chemotherapy agents administered at frequent intervals. This strategy is called metronomic chemotherapy. It is possible that combining agents like sorafenib and metronomic chemotherapy may further enhance anti-cancer effects. This study aims to determine the optimal way of combining oral vinorelbine in metronomic doses and sorafenib. Oral vinorelbine is a chemotherapy agent that is already approved for use in cancer treatment such as lung cancer. By combining both oral anti-cancer agents to optimize their anti-angiogenic effects in this study, the potential benefit to the patients can be tremendous and far-reaching. Special radiologic imagings and blood tests will be incorporated into this study to help further the understanding of the anti-angiogenic processes of both agents.

Timeline

Start
2008-06
Primary completion
2013-08
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 800 mg Oral
Subject Vinorelbine Small molecule 60 mg Oral
Subject Vinorelbine Small molecule 90 mg Oral
Subject Vinorelbine Small molecule 120 mg Oral