NCT00118300撤回1 期
Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating patients with locally advanced cervical cancer or other pelvic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicity of capecitabine when given in combination with pelvic external beam radiotherapy and intracavitary brachytherapy in patients with primary or recurrent locally advanced cervical cancer or other pelvic malignancy.
Secondary
- Determine the clinical anti-tumor response in patients treated with this regimen.
- Determine adverse clinical sequelae in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed cervical cancer or other pelvic malignancy, including vaginal, endometrial, or ovarian cancer
- •Primary or recurrent disease
- •Locally advanced disease, defined as the following:
- •Stage IB2-IVA (for cervical or vaginal cancer)
- •Any non-extra pelvic metastatic stage (for endometrial or ovarian cancer)
- •Not amenable to curative surgical resection alone
- •Bidimensionally measurable or clinically evaluable disease
- •Refused or ineligible for weekly IV cisplatin chemotherapy due to renal insufficiency, prior platinum adverse sensitivity, pre-existing neuropathy, or concurrent co-morbid illness
- •No histologically confirmed or clinically suspicious (≥ 1 cm) para-aortic lymphadenopathy
- •No brain metastases or primary brain tumors
- •PATIENT CHARACTERISTICS:
- •18 and over (80 and under for second and third dose-escalation levels)
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10.0 g/dL
- •Bilirubin ≤ 1.5 mg/dL
- •AST and ALT < 2 times upper limit of normal
- •See Disease Characteristics
- •Creatinine normal OR
- •Creatinine clearance ≥ 30 mL/min*
- •No proteinuria or clinically significant impaired renal function NOTE: *Creatine clearance testing required in patients > 60 years of age
- •Cardiovascular
- •No symptomatic New York Heart Association class III or IV congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled hypertension
- •Gastrointestinal
- •Able to swallow oral medication
- •No bowel obstruction
- •No malabsorption illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known hypersensitivity to capecitabine or fluorouracil
- •No ongoing or active infection
- •No other uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •No other active invasive malignancy
- •Prior malignancy in remission for ≥ 6 months that is not currently being treated allowed
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Recovered from prior chemotherapy
- 另有 13 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
时间窗: weekly
Disease response measured prior to brachytherapy and at 1 month after completion of study treatment
时间窗: 1 month after completion of study treatment
Toxicity as measured by CTC v 3.0 weekly
时间窗: weekly
次要结局
未报告次要终点
研究者
研究点 (4)
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