Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
Over the last few years several novel agents have been defined which are active in the treatment of relapsed epithelial ovarian carcinoma. Many of these new agents seemed to have mechanisms of action that are different from Carboplatin and taxol. This trial looks to evaluate the effectiveness and toxicity of three sequential chemotherapy doublets in the treatment of women with newly diagnosed ovarian, primary peritoneal or tubal carcinoma.
Fallopian Tube Cancer
Primary Peritoneal Cancer
Drug: Chemotherapy, multiple agents
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Michael V Seiden, M.D. Ph.D.||Massachusetts General Hospital|