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