NCT00040820已完成不适用
A Treatment Access Program With Oxaliplatin for Previously Treated Colorectal Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Clinical trial to study the effectiveness of oxaliplatin in treating patients who have locally advanced or metastatic colorectal cancer that has been previously treated.
详细描述
OBJECTIVES:
- Provide oxaliplatin for patients with previously treated locally advanced or metastatic colorectal cancer who have exhausted all approved therapies for colorectal cancer.
OUTLINE: This is a multicenter, Treatment Access Program study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for at least 30 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to surgical resection or other potentially curative therapy
- •Locally advanced OR
- •Metastatic disease
- •Patients who progressed on a non-oxaliplatin-containing (control) arm in Sanofi-Synthelabo second-line regulatory trials OR
- •Patients who have exhausted all approved therapies for colorectal cancer (including fluorouracil and irinotecan) and have received at least 2 prior independent/different chemotherapy regimens
- •Documented radiological disease progression after last anticancer treatment
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 75,000/mm3
- •SGOT or SGPT no greater than 6 times upper limit of normal (ULN)
- •Bilirubin no greater than 2 mg/dL
- •Alkaline phosphatase no greater than 5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study
- •Adequate organ function and medically stable
- •No known concurrent peripheral neuropathy
- •Absence of deep tendon reflexes as the sole neurologic abnormality is allowed
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •At least 30 days since prior chemotherapy
- •No prior oxaliplatin-based chemotherapy
- •No other concurrent investigational chemotherapy agents
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 30 days since prior radiotherapy
- •See Disease Characteristics
- •At least 30 days since prior major surgical procedure or intervention
- •At least 30 days since other prior anticancer therapy
- •No other concurrent anticancer agents
- •No concurrent participation in any other investigational studies
排除标准
- 未提供
研究者
研究点 (1)
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