A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin
Objective: To evaluate a novel regimen in ovarian carcinoma with an aim of demonstrating a
higher than 50% laparotomy defined response rate. This rate is defined as the proportion of
patients achieving either a pathologic complete response or a microscopic positive second
look at the conclusion of therapy.
Primary study goals:
· To determine the efficacy of a triple doublet regimen in carefully defined cohorts of
patients as defined by the surgical defined response rate
Secondary study goals:
- To evaluate incidence of tubulin mutations in primary and secondary surgical specimens.
- To evaluate changes in IL-6, IL-8, VEGF, and FGF, at primary diagnosis, during and at
the conclusion of therapy.
- To describe initial IL-6, IL-8, and FGF levels in patients who ultimately achieve
pathologic remission vs those with gross residual disease.
Patients will recieve 3 cycles of carboplatin and gemcitabine followed by 3 cycles of taxol
and carboplatin and then three cycles of adriamycin and topotecan. All patients with a
clinically complete response will then undergo second look operation to determine
pathologically defined response.
- SLO = Second Look Operation
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
Michael V Seiden, M.D. Ph.D.
Massachusetts General Hospital
United States: Institutional Review Board
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