A Randomized Phase III Trial of Gemzar Versus Doxil With Crossover Treatment Option for Patients With Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer Undergoing Second or Third-Line Chemotherapy

Trial ID # NCT00191607
Phase III
Drug Class Chemotherapy, Chemotherapy
Drug Name Liposomal doxorubicin, Gemcitabine
Alternate Drug Names Pegylated Liposomal Doxorubicin Hydrochloride, liposomal doxorubicin, LipoDox, Evacet, Dox-SL, Doxil, Gemzar
Drugs in Trial Liposomal doxorubicin, Gemcitabine
Eligible Participant

Platinum resistant ovarian cancer with ≤ 2 prior therapies

Patients Enrolled

195; median 1 prior therapy (1-2)

Therapy Setting


Study Design

Open-Label, Randomized


ORR, PFS, OS, evaluated per RECIST or CA125


PLD vs Gem:

ORR: 8.3% (2CR, 6PR, n=96) vs 6.1% (1CR, 5PR, n=99)(p=0.589)
ORR (w/ measurable disease): 11.7 vs 9.2%
DCR: 46.9% (2CR, 6PR, 37SD, n=96) vs 60.6% (1CR, 5PR, 54SD, n=99)
PFS: 3.1 vs 3.6 months
OS: 13.5 vs 12.7 months

Clinically Significant Adverse Events

PLD vs Gem:
Serious AE:
Grade 3-4 AE: neutropenia (19 vs 38%), nausea/vomiting (12 vs 4%), fatigue (1 vs 11%), hand-foot syndrome (PPE) (10 vs 0%)


Comparable efficacy for liposomal doxorubicin and gemcitabine with different toxicity profiles


Mutch et al. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol (2007) 25: 2811-2818

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