Trial ID # | NCT00003120; GOG-178 |
Phase | III |
Drug Class | Chemotherapy |
Drug Name | Paclitaxel |
Alternate Drug Names | Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL |
Drugs in Trial | Paclitaxel |
Eligible Participant | Stage III or IV disease with no evidence of progression after surgery and five or six cycles of platinum-taxane chemotherapy |
Patients Enrolled | 308 |
Therapy Setting | Maintenance |
Study Design | Open-Label, Randomized |
Endpoints | PFS, OS, evaluated per RECIST |
Efficacy | 12 cycles Pac vs 3 cycles Pac: PFS: 28 vs 21 months (p=0.0023) |
Clinically Significant Adverse Events | 12 cycles Pac vs 3 cycles Pac: |
Conclusion | Improved PFS with 12 cycles of paclitaxel, no OS difference |
Reference | Markman M et al. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J Clin Oncol (2003) 21(13):2460-5 Markman M et al. Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial. Gynecol Oncol (2009) 114(2):195-8 |