Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
|Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer||Drug: Chemotherapy, multiple agents||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin|
- · To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
- · 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 levels in patients who ultimately achieve pathologic remission vs those with gross residual disease at the time of SLO.
|Study Start Date:||December 2000|
|Study Completion Date:||July 2005|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157560
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Michael V Seiden, M.D. Ph.D.||Massachusetts General Hospital|