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 2
Study Type
Interventional
Primary Outcome
· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
Secondary Outcome
· To evaluate incidence of tubulin mutations in primary and secondary surgical specimens.
Condition
Ovarian Cancer
Intervention
Chemotherapy, multiple agents
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
83
Start Date
December 2000
Completion Date
July 2005
Primary Completion Date
November 2006
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 - N/A
Accepts Healthy Volunteers
No
Contacts
Michael V Seiden, M.D. Ph.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00157560
Organization ID
00-305
Study Sponsor
Massachusetts General Hospital
Collaborators
GlaxoSmithKline
Study Sponsor
Michael V Seiden, M.D. Ph.D., Principal Investigator, Massachusetts General Hospital
Verification Date
December 2007