The BAROCCO Study (Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib): an Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib With Continuous Schedule vs. Cediranib-Olaparib With Intermittent Schedule in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

Trial ID # NCT03314740; BAROCCO
Phase II
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
Drugs in Trial Cediranib, Olaparib
Eligible Participant

Platinum resistant ovarian cancer

Patients Enrolled

123 (median Pt-free interval 1.8 months; 59% of patients had > 3 prior therapies)

Therapy Setting


Study Design

Open-Label, Randomized


PFS, evaluated per RECIST


Exploratory: BRCA status


Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac:

PFS: 5.6 vs 3.8 vs 3.1 months, HR: 0.76 (0.50-1.14, p = 0.27); HR:1.03 (0.68-1.55, p = 0.90)

Exploratory analysis:
gBRCA WT (n=109): PFS: 5.8 vs 3.8 vs 2.1 months, HR: 0.63 (0.36-1.10, p = 0.10)

Clinically Significant Adverse Events

Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac:
Serious AE: 2 deaths; 1 in Ola+Ced (continous), 1 in Pac
Grade 3-4 AE:


The combination of olaparib and cediranib is not superior to chemotherapy in terms of PFS in heavily pretreated platinum resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population


Colombo N et al. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer. Gynecol Oncol (2022) 164(3):505-513

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