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
Drug Name Gemcitabine, Liposomal doxorubicin
Alternate Drug Names Gemzar, Doxil, Dox-SL, Evacet, LipoDox, liposomal doxorubicin, Pegylated Liposomal Doxorubicin Hydrochloride
Drugs in Trial Gemcitabine, Liposomal doxorubicin
Eligible Participant

Platinum-resistant ovarian cancer, ≤2 prior regimens

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