Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157560
Status:
COMPLETED
Last Update Posted:
2008-01-03
First Post:
2005-09-07
Brief Title:
Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None