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, 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


Therapy Setting


Study Design

Open-Label, Randomized


ORR, PFS, OS, evaluated per RECIST


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%)


Improved PFS with addition of gemcitabine


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(20):4699-707

Contact Us
Contact Us

We are here to help! Send us a message below or give us a call at (858) 657-0282.