NCT00157560已完成2 期
A Phase II Trial of ModifiedTriple Doublet Therapy in the Treatment of Women With Newly Diagnosed Carcinoma of Müllerian Origin
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- · To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 #
- •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) >
- •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/mm
- •Exclusion Criteria
排除标准
- 未提供
结局指标
主要结局
· To determine the efficacy of the triple doublet regimen as defined by second look laparotomy
次要结局
- · 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.
研究者
研究点 (2)
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