Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO)

Trial ID # NCT00538603; CALYPSO
Phase III
Drug Class Chemotherapy
Drug Name Carboplatin, Liposomal doxorubicin, Paclitaxel
Alternate Drug Names Paraplatin, Novoplatinum, Doxil, Dox-SL, Evacet, LipoDox, liposomal doxorubicin, Pegylated Liposomal Doxorubicin Hydrochloride, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL
Drugs in Trial Carboplatin, Liposomal doxorubicin, Paclitaxel
Eligible Participant

Platinum-sensitive ovarian cancer at recurrence following first- or second line platinum-based chemotherapy and prior taxane therapy

Patients Enrolled

976

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

CarboPt+PLD vs CarboPt+Pac:

PFS: 11.3 vs 9.4 months, HR: 0.82 (0.72-0.94, p=0.005)
OS: 30.7 vs 33.0 months, HR: 0.99 (0.85-1.16, p=0.94)

Clinically Significant Adverse Events

CarboPt+PLD vs CarboPt+Pac:
Serious AE: two treatment related fatalities in CarboPt+PLD arm: 1 cerebral hemorrhage and 1 acute myeloid leukemia
Grade 3-4 AE: any severe non-hematologic toxicity (28.4 vs 36.8%), alopecia (grade 2 or greater) (7 vs 83.6%), sensory neuropathy (4.9 vs 26.9%), hypersensitivity reactions (5.6 vs 18.8%), PPE (mostly grade 2) (12.0 vs 2.2%), nausea (35.2 vs 24.2%)

Conclusion

Carboplatin+PLD has similar PFS and OS to carboplatin+paclitaxel with less sensory neuropathy

Reference

Wagner U et al. Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients. Br J Cancer (2012) 107: 588-591
https://www.ncbi.nlm.nih.gov/pubmed/22836511