| Trial ID # | NCT00326456; MITO-2 |
| Phase | III |
| Drug Class | Chemotherapy, Chemotherapy, Chemotherapy |
| Drug Name | Carboplatin, Liposomal doxorubicin, Paclitaxel |
| Alternate Drug Names | Paraplatin, Novoplatinum, Pegylated Liposomal Doxorubicin Hydrochloride, liposomal doxorubicin, LipoDox, Evacet, Dox-SL, Doxil, Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat, TXL |
| Drugs in Trial | Carboplatin, Liposomal doxorubicin, Paclitaxel |
| Eligible Participant | Newly diagnosed stage IC-IV ovarian cancer |
| Patients Enrolled | 820 |
| Therapy Setting | First-line |
| Study Design | Open-Label, Randomized |
| Endpoints | PFS, OS, evaluated per RECIST |
| Efficacy | CarboPt+Pac vs CarboPt+PLD: PFS: 16.8 vs 19.0 months, HR: 0.95 (0.81-1.13, p=0.58) |
| Clinically Significant Adverse Events | CarboPt+Pac vs CarboPt+PLD: Grade 3-4 AE: anemia (3 vs 10%), thrombocytopenia (7 vs 16%) |
| Conclusion | No significant PFS or OS difference when paclitaxel or liposomal doxorubicin is added to carboplatin, but different toxicity profiles |
| Reference | Pignata S et al. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. J Clin Oncol (2011) 29(27):3628-35 |
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