Celgene has announced preliminary clinical data comparing the efficacy and safety of the combination of thalidomide and topotecan versus topotecan. The two drugs are being studied in a Phase II clinical study for the treatment of recurrent epithelial ovarian cancer in patients who had received prior treatments.
This multicenter, prospective, randomized trial enrolled 75 women between April 2001 and July 2005. Based on an intent-to-treat analysis, the study evaluated 69 women. Six patients were excluded for never receiving treatment, and patients who were not assessable for response were considered non-responders. Eligible patients had recurrent or persistent epithelial ovarian carcinoma as documented by exam, imaging study or elevated CA-125.
The median thalidomide dose was 200 mg/day, and toxicities were similar between both groups. Adverse events observed were fatigue, constipation, peripheral neuropathy and deep vein thrombosis.