NCT00024375Unknown2 期
Phase II Open-Label Study of Taxoperxin (DHA-Paclitaxel) Injection by 2 Hour Intravenous Infusion in Patients With Metastatic Cancer of the Pancreas
Theradex18 个研究点 分布在 4 个国家开始时间: 2001年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 18
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: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic pancreatic cancer.
详细描述
OBJECTIVES:
- Determine the tumor response rate, duration of response, and time to disease progression in patients with metastatic carcinoma of the pancreas treated with DHA-paclitaxel.
- Determine the overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Assess the quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 courses, and at completion of treatment.
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 carcinoma of the pancreas
- •Metastatic disease
- •Measurable disease
- •Lesions within a previously irradiated field are not considered measurable
- •No islet cell tumors, lymphoma, or sarcoma of the pancreas
- •No known or clinical evidence of CNS metastasis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No uncontrolled ventricular arrhythmia
- •No myocardial infarction within the past 3 months
- •No superior vena cava syndrome
- •Neurologic:
- •No peripheral neuropathy greater than grade 1
- •No uncontrolled major seizure disorder
- •No spinal cord compression
- •No concurrent serious infection requiring parenteral therapy
- •No unstable or serious concurrent medical condition
- •No other prior malignancy except:
- •Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR
- •Other cancer curatively treated with surgery alone that has not recurred for more than 5 years
- •No psychiatric disorder that would preclude study compliance
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study therapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior chemotherapy for metastatic disease
- •Prior adjuvant chemoradiotherapy allowed
- •At least 28 days since prior chemotherapy and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy except megestrol
- •Radiotherapy:
- •See Disease Characteristics
- •Prior adjuvant chemoradiotherapy allowed
- •At least 28 days since prior large-field radiotherapy and recovered
- •No concurrent radiotherapy
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (18)
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