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Phase II Study of Modified Triple Doublet Therapy in Women With Newly Diagnosed Mullerian Carcinoma

This study has been completed.
Study NCT00157560.   Last updated on December 28, 2007.   Information provided by Massachusetts General Hospital

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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.

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
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.
Condition  Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Intervention  Drug: Chemotherapy, multiple agents
MEDLINE PMIDs
Links Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  83
Start Date  December 2000
Completion Date July 2005
Eligibility Criteria 

Inclusion Criteria:

  • Histologically confirmed epithelial carcinoma of müllerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma will be allowed. All histologic subtypes are eligible.

    • Patients must have undergone an attempt at aggressive surgical debulking or alternatively be eligible for interim debulking after cycle #3. Patients debulked to no evidence of disease, microscopic disease or gross residual disease are eligible.
    • Stage II, III or IV disease. Patients with disease outside the abdominal cavity are eligible unless presentation includes brain metastases.
    • Able and willing to undergo a second look staging laparotomy.
    • Patients must give written informed consent.
    • Patient must be ag· Performance status (ECOG) >2.
    • Previous chemotherapy.
    • Creatinine > 1.5
    • History of recent MI or congestive heart failure within 6 months of surgery
    • SGOT > 2x ULN, bilirubin > 1.5 X ULN
    • Concurrent invasive malignancy. (Patients with concurrent superficial endometrial carcinoma are eligible if their endometrial carcinoma is superficial or invades less than 50% the thickness of the myometrium).
    • Known hypersensitivity to E.coli derived products?
    • Active psychiatric or mental illness that makes informed consent or careful clinical follow-up unlikely e 18 years or older.
    • Adequate bone marrow function with an ANC > 2,500 and Platelets >100,000/mm3.

Exclusion Criteria

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
Investigators 
Principal Investigator:     Michael V Seiden, M.D. Ph.D.     Massachusetts General Hospital    
Information Provided By Massachusetts General Hospital
Verification Date December 2007
First Received Date  September 7, 2005
Last Updated Date December 28, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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