1. Randomized Phase III Study Of Gemcitabine
(GEM) vs Pegylated Liposomal Doxorubicin
(PLD) in progressive/recurrent ovarian cancer

2. Secondary Objective(s):
Randomized Phase III Study Of Gemcitabine (GEM) vs Pegylated Liposomal Doxorubicin (PLD) in progressive/recurrent ovarian cancer
Primary Objective:
Compare TTP in progressive/recurrent ovarian cancer patients failing platinum/paclitaxel-based chemotherapy
Secondary Objective(s):
Overall Survival (OS)
Response Rate (RR)
Duration of response
Safety/toxicity
QoL
Sample size: a total of 147 pts is needed (Alpha=0.05, Beta=0.8), in order to detect a difference in the hazard ratio of 58% (median TTP 12 to 19 weeks)

3. Inclusion Criteria
Recurrent OC failing platinum/paclitaxel CT and measurable or
evaluable lesions
No more than one prior CT with a platinum+taxane regimen and
treatment-free interval <12 months
Age >18
ECOG Performance status < 2 , life expectancy >12 weeks
Normal haematological, renal, hepatic, cardiac, respiratory function
LVEF >50%
Written informed consent

4. Exclusion Criteria Previous or current malignancies at other sites
Brenner’s and borderline ovarian tumors
Hb<9gr/dL; ANC<1500/uL; PLT<100000/uL; Creat.>1.5mg/dL or
Creat. clear.<50 cc/min; Bil. >1.5mg/dL; AST,ALT>1.5 normal
Other investigational cytotoxic drug within 4 weeks before
Uncontrolled severe, viral, fungal or parasitic infection
Symptomatic CNS metastases
Severe medical problems unrelated to malignancy limiting compliance
with the study or exposing the patient to extreme risk

5. Study Design GEMCITABINE: 1000 mg/m2 d1,8,15 q28 PLD: 40 mg/m2 d1 q28
(until progression of disease or unacceptable toxicity)
Evaluation of response: every two cycles (RECIST)

6. Patient Characteristics at Diagnosis
GEM PLD
Enrolled 77 76
FIGO stage
I-II
III IV 3 51 23 4 49 23
Grading
1-2 3
n.a. 15 48 14 12 50 14
Histotype
Serous
Undifferentiated
Clear cell
Endometrioid
Mucinous
Mixed 59 4 6 5 1 2 64 2 4 3 1
Mito 3

7. Patient Characteristics at Recurrence
GEM PLD
Recruited 77 76
Age yrs (median,range)
63 ( )
63 ( )
PFI
< 6 months (55.8%) (56.6%)
months (44.2%) (43.4%)
PS (ECOG) 0/1/ /33/ /39/4
Recurrence (site)
Abdominal
Lymph node
Pelvis
Mixed 25 8 36 24 6 12 34
CA125 (IU/ml (range)) ( ) ( )
Mito 3

8. Study Drug Administration Details
GEM PLD
Total Cycles administered
269
290
Median No. Cycles/patient (range)
3.0 (1 - 12)
3.5 (1 - 14)
Median cumulative dose/patient (mg/mq) (range)
9,000
(1, ,000)
120
( )
No Cycles with delay
13 (4.5%)
32 (11.8%)
No Cycles with reduction
24 (8.3%)
22 (8.2%)
Mito 3