Phase III Randomized Trial of 12 Months vs. 3 Months of Paclitaxel in Patients With Advanced Ovarian Cancer Who Attain a Clinically Defined Complete Response (CR) Following Platinum/Paclitaxel-Based Chemotherapy (GOG-178)

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)
OS: 53 vs 48 months (p=0.34)

Clinically Significant Adverse Events

12 cycles Pac vs 3 cycles Pac:
Serious AE: none
Grade 3-4 AE: neuropathy (5 vs 1%)

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
https://www.ncbi.nlm.nih.gov/pubmed/12829663

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) 114:195-8
https://www.ncbi.nlm.nih.gov/pubmed/19447479