TY - JOUR T1 - Phase I/II study of tandem cycles of high-dose chemotherapy followed by autologous hematopoietic stem cell support in women with advanced ovarian cancer JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer SP - 57 LP - 64 DO - 10.1136/ijgc-00009577-200601000-00010 VL - 16 IS - 1 AU - A. Tiersten AU - M. Selleck AU - D. H. Smith AU - I. Wertheim AU - E. Kaufman AU - D. Hershman AU - L. T. Vahdat AU - D. G. Savage AU - R. B. Macarthur AU - C. Hesdorffer Y1 - 2006/01/01 UR - http://ijgc.bmj.com/content/16/1/57.abstract N2 - The objectives of this study were to investigate the tolerability of a novel high-dose chemotherapy (HDC) regimen with peripheral blood progenitor cell (PBPC) support in patients with pretreated advanced ovarian cancer and to determine the maximum-tolerated dose (MTD) of topotecan in this setting. Advanced ovarian cancer patients previously treated with platinum-based first-line therapy were enrolled. After PBPC mobilization and harvesting, patients received three consecutive cycles of HDC with PBPC support. Cycle 1 was carboplatin area under the concentration curve 20 and paclitaxel 250 mg/m2. Cycle 2 was topotecan starting at 5 mg/m2, dose escalated in 2 mg/m2 increments, and etoposide 600 mg/m2. Cycle 3 was thiotepa 500 mg/m2. After each cycle, PBPCs were infused. Granulocyte colony stimulating factor (5 μg/kg/day) was administered until neutrophil recovery occurred. Seventeen patients were enrolled; all were safety evaluable. The most common nonhematologic toxicity was grade 3 mucositis (44%). Engraftment of PBPCs was successful in all patients after each cycle, and no treatment-related deaths occurred. Of 14 patients with measurable disease, 5 (36%) had complete responses, 2 (14%) had partial responses, and 4 (29%) had stable disease. The median progression-free and overall survivals were 7 and 18 months, respectively. The MTD of topotecan was not reached. The tolerability and activity of this regimen in patients with advanced ovarian cancer warrant further investigation. ER -