NCT00072332已完成1 期
A Phase I Dose Escalation Study of Edotecarin (PHA-782615) and Cisplatin in Adult Patients With Advanced/Metastatic Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as edotecarin and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining edotecarin with cisplatin may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining edotecarin with cisplatin in treating patients who have advanced or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended phase II dose of edotecarin when administered with cisplatin (administered in 2 different schedules) in patients with advanced or metastatic solid tumors.
Secondary
- Determine the safety profile of this regimen in these patients.
- Determine the plasma pharmacokinetics of this regimen in these patients.
- Determine the antitumor activity of this regimen in these patients.
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:
- •Diagnosis of one of the following:
- •Histologically or cytologically confirmed active solid tumor malignancy
- •Histologically confirmed esophageal or gastric cancer* meeting all the following criteria:
- •Previously untreated disease
- •Metastatic disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR 10 mm by spiral CT scan NOTE: *Patients with esophageal or gastric cancer are enrolled after the maximum tolerated dose has been determined
- •No known brain or leptomeningeal disease
- •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
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN) (regardless of liver involvement by tumor)
- •SGOT no greater than 3 times ULN (5 times ULN if there is liver involvement by tumor)
- •Albumin at least 3.0 g/dL
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular
- •None of the following within the past 12 months:
- •Myocardial infarction
- •Severe/unstable angina
- •Symptomatic congestive heart failure
- •Cerebrovascular accident
- •Transient ischemic attack
- •Deep vein thrombosis
- •Other significant thromboembolic event
- •No ongoing grade 2 or greater cardiac dysrhythmia
- •No atrial fibrillation
- •No pulmonary embolism within the past 12 months
- •Gastrointestinal
- •No active inflammatory bowel disease
- •No partial or complete bowel obstruction
- •No chronic diarrhea
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No grade 2 or greater acute toxic effects
- •No active infection
- •No other concurrent acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior treatment with any of the following systemic therapies for metastatic cancer*:
- •Antibody therapy
- •Immunotherapy
- 另有 27 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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