A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin
18 Years
N/A
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Trial Information
A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
Principal Investigator
Michael V Seiden, M.D. Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Institutional Review Board
Study ID:
00-305
NCT ID:
NCT00157560
Start Date:
December 2000
Completion Date:
July 2005
Related Keywords:
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
- Carcinoma
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
