NCT00062257已完成2 期
A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
Cancer Therapeutics Research Group11 个研究点 分布在 5 个国家开始时间: 2003年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 11
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well irofulven works in treating patients with recurrent or metastatic gastric cancer.
详细描述
OBJECTIVES:
- Determine the response rate of patients with recurrent or metastatic gastric cancer treated with irofulven.
- Determine the toxicity profile of this drug in these patients.
- Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression, unacceptable toxicity, or static disease after 4 courses in the absence of clinical benefit.
Patients are followed for survival.
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 or cytologically confirmed gastric adenocarcinoma
- •Recurrent or metastatic disease
- •Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction
- •Measurable disease
- •At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No active disseminated intravascular coagulation
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases)
- •Alkaline phosphatase no greater than 5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven
- •No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •No other uncontrolled concurrent illness that would preclude study participation
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •Must have central or peripherally inserted central catheter
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa
- •Chemotherapy
- •No prior chemotherapy for recurrent or metastatic disease
- •Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy and recovered
- •Not specified
- •No other concurrent investigational or commercial agents or therapies for the malignancy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究者
研究点 (11)
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