NCT00287885已完成1 期
Phase I Study of Metronomic Daily Dosing of Docetaxel in Women With Progressive or Recurrent Gynecologic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Docetaxel may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving daily doses of docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel in treating patients with refractory or recurrent advanced gynecologic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine the pharmacokinetics associated with this drug in these patients.
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
- •Patients must have histologically confirmed advanced, refractory gynecologic cancer.
- •Patients must have received prior chemotherapy, and must have residual or recurrent disease after initial therapy or after subsequent therapy.
- •Patients must have at least one site of bi-dimensional measurable disease as defined in section 9 or must have evaluable but radiographically non-measurable disease associated with CA-125 > 50 units/ml on two measurements at least one week apart. Baseline measurements and CA-125 must be obtained for all patients within four weeks before registration.
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must not have received any hormonal or immunologic therapy for 2 weeks or cytotoxic chemotherapy or radiation therapy for 4 weeks (nitrosoureas and mitomycin C require 6 weeks) prior to registration.
- •Patients may not have a history of prior malignancy in the past 5 years other than non-melanoma skin cancer or in situ carcinoma of the cervix.
- •Patients must have documented adequate organ function within 4 weeks of registration defined as:
- •Marrow: WBC ≥ 3000/mm3, ANC ≥ 1500/mm3 , Hgb ≥ 8.0 g/dl, platelets ≥ 100,000/mm3
- •Hepatic: Total Bilirubin ≤ ULN, SGOT or SGPT and Alkaline Phosphatase must be within the range allowing for eligibility, as in the table below
- •SGOT or SGPT: Meets 1 of the following criteria:
- •Alkaline phosphatase (AP) normal AND SGOT or SGPT normal
- •AP ≤ 5 times ULN AND SGOT or SGPT normal
- •AP normal AND SGOT or SGPT ≤ 5 times ULN
- •AP ≤ 2.5 ULN AND SGOT or SGPT ≤ 1.5 times ULN
- •Renal: BUN ≤ 30 mg%, creatinine ≤ 1.5 mg%
- •Age ≥ 18 years
排除标准
- •Pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk.
- •Patients of reproductive potential must use effective birth control, preferably with barrier methods.
- •Prior history of myocardial infarction, congestive heart failure or significant ischemic or valvular heart disease.
- •Patients with known brain metastases are not eligible.
- •Peripheral neuropathy must be ≤ grade
- •Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
- •Patient must given written informed consent indicating the investigational nature of the treatment and its potential risks
研究组 & 干预措施
Metronomic Docetaxel
Experimental
Docetaxel will be administered by daily injection via pre-filled syringes into the patient's accessed subcutaneous port.
干预措施: docetaxel (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: Up to 180 Days
Determine the maximum tolerated dose of metronomic docetaxel in patients with progressive or recurrent gynecologic cancer
次要结局
- Response to Treatment(Up to 180 Days)
- Pharmacokinetics(Day 1 through Day 5)
研究者
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