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


Therapy Setting


Study Design



ORR, PFS, OS, evaluated per RECIST


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%)


Improved PFS and OS with addition of paclitaxel


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

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