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	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST or CA125
Efficacy	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%)
Conclusion	Comparable efficacy for liposomal doxorubicin and gemcitabine with different toxicity profiles
Reference	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 https://www.ncbi.nlm.nih.gov/pubmed/17602086