FIGO Stages II to IV Clinical Trial
Official title:
Addition of Decitabine to Carboplatin-Paclitaxel in First-Line Treatment of Advanced Ovarian Cancer: A Phase 2-3, Open-label, Randomised Controlled Trial
Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer
death in women. Most patients are typically diagnosed with advanced-stage disease.
Platinum-paclitaxel regimen has been widely adopted as a standard first-line treatment for
advanced ovarian cancer. Multiple collaborative randomised phase III trials evaluating the
addition of a third chemotherapy agent, maintenance therapy or alternative taxanes failed to
demonstrate significant improvements over a standard carboplatin/taxane doublet.
Decitabine (DAC), one major DNA demethylating agent, has been approved for treatment of
preleukemic hematological disease myelodysplastic syndrome (MDS) by the Food and Drug
Administration. Past trials of these with high doses, i.e., the use of maximal tolerated
dose, for patients with solid tumors showed a low therapeutic index, due to extreme
toxicities that have probably confounded the ability to document the true clinical response.
Low dose DNA demethylation agent decitabine (DAC) can resensitize the therapeutic indexes of
resistent ovary cancer cells in vivo and in vitro.
The investigators hypothesized that DAC-triggered epigenetic reprogramming of tumor cells
and possible immune cells could induce pronounced long-dated clinical effect by
chemosensitization- and immunopotentiation-driven maximal eradicating roles on the
minimal/residual lesions in primary patients with poor prognosis.
Given the poor prognosis and the currently existed therapeutic strategies, The investigators will perform a prospective, randomized, phase II to III, intergroup trial to compare carboplatin plus paclitaxel (TC) with the DAC-primed TC (DTC) regimen in previously untreated patients with stage II to IV ovarian cancer. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment