BACKGROUND: Currently, no clearly superior management strategy exists for 
recurrent, platinum-resistant ovarian cancer. We tested the efficacy and safety 
of gemcitabine combined with oxaliplatin (GEMOX) in a multicentre phase II 
clinical trial.
METHODS: Forty one patients with recurrent, platinum-resistant ovarian cancer 
were enrolled. Prior to study entry, all the participants had received at least 
one platinum-based regimen. Gemcitabine was administered at 1000 mg/m2 as 
protracted infusion (100 min) on day 1, and oxaliplatin at the dose of 100 mg/m2 
on day 2 in a 2 hour infusion. Cycles were repeated every two weeks.
RESULTS: We observed an overall response rate of 37% [95% Confidence Interval 
(CI), 22.3-51.7]. Objective responses plus disease stabilization (clinical 
benefit) occurred in 78% of patients. Median progression-free survival was 
6.8 months (95% CI, 5.8-7.8), and median overall survival was 16.5 months (95% 
CI, 12.2-20.8). Median time to self-reported symptom relief, which was described 
by 22 out of 27 symptomatic patients (81.5%), was 4 weeks (range, 2-8). Grade 4 
neutropenia and febrile neutropenia were observed in 2 (5%) and 1 (2.5%) 
patients, while grade 3 anemia was encountered in 2 (5%) patients, respectively. 
The most common adverse effects of any grade were gastrointestinal symptoms, 
fatigue and neutropenia. Nine patients (22%) experienced mild allergic reaction 
to oxaliplatin, with no treatment discontinuation.
CONCLUSIONS: In our cohort of recurrent, platinum-resistant ovarian cancer 
patients, GEMOX showed encouraging activity and manageable toxicity. Under 
circumstances requiring a rapid disease control, this combination regimen may 
offer a particularly viable option, particularly in heavily pretreated patients.