NCT00281788已完成1 期
A Phase I Study of Oral Capecitabine in Combination With Weekly IV Carboplatin/Paclitaxel and Radiation Therapy for Patients
Duke University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2003年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, carboplatin, and paclitaxel, 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 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 carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal cancer or gastroesophageal junction cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of capecitabine when administered with carboplatin, paclitaxel, and radiotherapy in patients with carcinoma of the esophagus or gastroesophageal junction.
Secondary
- Determine the radiographic and pathologic response rate in patients treated with this regimen.
- Correlate, preliminarily, tumor biomarker response with clinical response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed carcinoma of the thoracic esophagus or gastroesophageal junction for which bimodality treatment with chemotherapy and radiotherapy is indicated
- •No tumors that extend above the level of the thoracic inlet or beyond 4 cm below the gastroesophageal junction
- •No esophageal perforation based on radiographic or bronchoscopic evidence
- •No known brain metastases, lymphangitic lung metastases, or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status ≥ 70%
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •AST or ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine ≤ 1.5 times ULN
- •Calcium ≤ 1.3 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection or other serious underlying medical condition that would preclude study treatment
- •No dementia or significantly altered mental status that would preclude understanding or giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy
- •No other concurrent investigational therapy
排除标准
- 未提供
研究者
研究点 (2)
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