A Randomized Trial of Paclitaxel (Taxol) in Combination With Platinum Chemotherapy vs. Conventional Platinum-Based Chemotherapy in the Treatment of Women With Relapsed Ovarian Cancer (ICON4)

Trial ID # NCT00002894; ICON4
Phase III
Drug Class Chemotherapy
Drug Name Paclitaxel
Alternate Drug Names Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL
Drugs in Trial Carboplatin, Cisplatin, Paclitaxel
Eligible Participant

Platinum-sensitive ovarian cancer at recurrence after first-line Pt-based chemotherapy

Patients Enrolled

802

Therapy Setting

Recurrence

Study Design

Randomized

Endpoints

ORR, PFS, OS, evaluated per RECIST

Efficacy

CisPt/CarboPt+Pac vs CisPt/CarboPt:

ORR: 66 vs 54% (p=0.06)
PFS: 12 vs 9 months, HR: 0.76 (0.66-0.89, p=0.0004)
OS: 29 vs 24 months, HR: 0.82 (0.69-0.97, p=0.023)

Clinically Significant Adverse Events

CisPt/CarboPt+Pac vs CisPt/CarboPt:
Serious AE: none
Grade 3-4 AE: neuropathy (20 vs 1%), alopecia (86 vs 25%), hematological toxicity (29 vs 46%)

Conclusion

Improved PFS and OS with addition of paclitaxel

Reference

Parmar MK et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial. Lancet (2003) 361(9375):2099-106
https://www.ncbi.nlm.nih.gov/pubmed/12826431