NCT00025454已完成1 期
Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors
City of Hope Medical Center8 个研究点 分布在 1 个国家开始时间: 2001年8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
- 试验地点
- 8
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 I trial to study the effectiveness of R115777 in treating patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors.
- Assess the toxicity of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug in these patients.
- Determine the potential predictors of response in patients treated with drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
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 confirmed malignant tumors deemed to be incurable or refractory to therapy
- •Advanced, recurrent, or metastatic disease
- •Previously treated with at least 1 chemotherapy regimen
- •Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,500/mm3
- •Absolute granulocyte count at least 1,500/mm3
- •Platelet count at least 75,000/mm3
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Creatinine clearance at least 60 mL/min OR
- •Creatinine no greater than 1.6 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent biologic therapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea)
- •Endocrine therapy:
- •See Disease Characteristics
- •No concurrent hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present
- •No concurrent radiotherapy to measurable lesions
- •See Disease Characteristics
- •At least 3 weeks since prior major surgery and recovered
- •At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole)
- •Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between H2 blocker/antacid intake and R115777 dosing
排除标准
- 未提供
研究者
研究点 (8)
Loading locations...
相似试验
已完成
2 期
S9923 R115777 in Treating Patients With Advanced Colorectal CancerColorectal CancerNCT00005833SWOG Cancer Research Network62
已完成
2 期
S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic CancerPancreatic CancerNCT00005832SWOG Cancer Research Network58
已完成
2 期
R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone TherapyProstate CancerNCT00005848Fox Chase Cancer Center7
已完成
1 期
Chemotherapy in Treating Patients With Breast CancerBreast CancerNCT00012129NYU Langone Health
已完成
1 期
Irinotecan Plus Raltitrexed in Treating Patients With Refractory Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00003109Fox Chase Cancer Center39