Front-line @entity1311 and topotecan chemotherapy in advanced or metastatic XXXX : a phase II trial.

@entity1 @entity137 @entity1261 @entity882 @entity417 @entity5 @entity1149 @entity1311 @entity1398
PURPOSE: Based on previous experience, we combined topotecan with @entity1311 (weekly administration) in @entity1 with @entity1149 ( @entity1149 ). Our primary objective was to determine the response rate and survival and our secondary objective, the safety of the regimen. METHODS: From October 2003, until March 2005, 45 @entity1 all with histologically or cytologically confirmed @entity1149 were enrolled. All @entity1 were chemotherapy and radiotherapy naive. Both agents were infused on day 1 of every week once for three consecutive weeks, every 28 days. Three infusions were considered as one course. The treatment plan was to give three courses (nine infusions) and then to evaluate the response. Topotecan (1.75 mg/m2) was infused for 30 min and @entity1311 (70 mg/m2) for 90 min; these doses had been established as the maximum tolerated dose in a previous phase I-II trial. RESULTS: Eighteen/45 (40%) @entity1 responded, 2 (4.4%) complete responses and 16 (35.6%) partial responses. Twenty-one (46.7%) @entity1 had stable disease, and 6 (13.3%) disease progression. The median duration of response was 8 months and median time to @entity5 progression 9 months. Grade 3 and 4 @entity1398 was observed in two @entity1 (in these two @entity1 , the dose of both drugs was reduced by 25% and @entity1261 was given), grade 4 @entity882 in one @entity1 and grade 4 @entity417 in one @entity1 . CONCLUSION: This novel combination of topotecan- @entity1311 in a weekly administration rendered a 40% response rate, with very low @entity137 in stages IIIA, IIIB and IV @entity1149 @entity1 .
