A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy (NCIC OV15)

Trial ID # NCT00102414; NCIC OV15
Phase III
Drug Class Chemotherapy
Drug Name Carboplatin, Gemcitabine
Alternate Drug Names Paraplatin, Novoplatinum, Gemzar
Drugs in Trial Carboplatin, Gemcitabine
Eligible Participant

Platinum-sensitive ovarian cancer at recurrence following first-line platinum-based chemotherapy

Patients Enrolled

356

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Gem vs CarboPt:

ORR: 47.2 vs 30.9% (p=0.0016)
PFS: 8.6 vs 5.8 months, HR: 0.72 (0.58-0.90, p=0.003)
OS: 18.0 vs 17.3 months, HR: 0.96 (0.75-1.23, p=0.735) (71% maturity, not powered for OS)

Clinically Significant Adverse Events

CarboPt+Gem vs CarboPt:
Serious AE: none
Grade 3-4 AE: anemia (27.4 vs 9.0%), neutropenia (70.3 vs 12.0%), thrombocytopenia (34.9 vs 11.4%), RBC tranfusions (27.0 vs 6.7%), G-CSF/GM-CSF use (23.6 vs 10.1%)

Conclusion

Improved PFS with addition of gemcitabine

Reference

Pfisterer J et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol (2006) 24:4699-4707
https://www.ncbi.nlm.nih.gov/pubmed/16966687