Anti-angiogenic Chemotherapy: A Phase II Trial of the Oral 5-Drug Regimen(Thalidomide, Celecoxib, Fenofibrate, Etoposide and Cyclophosphamide) in Patients with Relapsed or Progressive Cancer
Drugs that attack the process of neovascularization, including endothelial cell proliferation, migration and/or tube formation, have anti-angiogenic activity. Chemotherapy, which possesses significant anti-proliferative activity can thus be used to target tumor vasculature as well as the tumor cells themselves. By altering the dose and schedule of a number of chemotherapeutic agents, this activity can be optimized to inhibit neovascularization, required for tumor growth and progression, while minimizing toxicity. A combination of 5 oral agents will be used in a ‘low-dose’ anti-angiogenic schedule designed to target the tumor vasculature. The drugs will include continuous oral administration of thalidomide, fenofibrate and celecoxib with alternating 21-day courses of oral etoposide and oral cyclophosphamide. Patients with poor prognosis disease will be eligible for this protocol. Treatment will be initiated for 27 weeks duration and may be extended depending on tolerability and response. This study will assess the feasibility of this treatment regimen, as well as gather data on the efficacy and toxicity of this approach. A number of biologic parameters will be examined to assess response.
This is the trial that Eden will be starting next week. Just wanted to let everyone know what had been decided on!