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| Descriptive Information Fields | |||||
| Brief Title † | Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma | ||||
| Official Title † | A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin | ||||
| 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. |
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| 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:
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.
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | · To determine the efficacy of the triple doublet regimen as defined by second look laparotomy | ||||
| Secondary Outcome Measure † | · 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. |
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| Condition † | Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer |
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| Intervention † | Drug: Chemotherapy, multiple agents | ||||
| MEDLINE PMIDs | |||||
| Links | Related Info ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 83 | ||||
| Start Date † | December 2000 | ||||
| Completion Date | July 2005 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00157560 | ||||
| Organization ID | 00-305 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Massachusetts General Hospital | ||||
| Collaborators †† | GlaxoSmithKline Eli Lilly and Company |
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| Investigators † |
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| Information Provided By | Massachusetts General Hospital | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | September 7, 2005 | ||||
| Last Updated Date | December 28, 2007 | ||||