Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group Study.

Trial ID # GOG-158
Phase III
Drug Class Chemotherapy
Drug Name Carboplatin, Cisplatin, Paclitaxel
Alternate Drug Names Paraplatin, Novoplatinum, CACP, cis-DDP, cis-platinum, CDDP, Platinol, Abiplatin , Blastolem , Briplatin , Cisplatyl , Citoplatino , Citosin , Lederplatin , Metaplatin , Neoplatin , Placis, Platamine , Platiblastin , Platiblastin-S , Platinex , Platiran, Platistin, Platosin, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL
Drugs in Trial Carboplatin, Cisplatin, Paclitaxel
Eligible Participant

Newly diagnosed stage III ovarian cancer (optimally debulked)

Patients Enrolled

840

Therapy Setting

First-line

Study Design

Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

CisPt+Pac vs CarboPt+Pac:

PFS: 19.4 vs 20.7 months, RR: 0.88 (0.75-1.03, p=NS)
OS: 48.7 vs 57.4 months, RR: 0.84 (0.70-1.02, p=NS)

Clinically Significant Adverse Events

CisPt+Pac vs CarboPt+Pac:
Grade 3-4 AE: leukopenia (63 vs 59%), thrombocytopenia (5 vs 39%), granulocytopenia (93 vs 89%), GI events (23 vs 10%)

Conclusion

No PFS or OS difference between cisplatin+paclitaxel and carboplatin+paclitaxel in optimally debulked stage III patients

Reference

Ozols RF et al. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol (2003) 21(17):3194-200
https://www.ncbi.nlm.nih.gov/pubmed/12860964