NCT00070031已完成2 期
A Phase II Study of Intravenous Edotecarin (PHA-782615) in Patients With Anthracycline- and Taxane-Refractory or Chemoresistant Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 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 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well edotecarin works in treating women with locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of edotecarin in women with anthracycline- and taxane-refractory or chemoresistant locally advanced or metastatic breast cancer.
Secondary
- Determine the time to tumor response and duration of response in patients treated with this drug.
- Determine the overall survival of patients treated with this drug.
- Determine the clinical benefit of this drug in these patients.
- Determine the safety and tolerability of this drug in these patients.
- Determine the pharmacokinetics of this drug 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
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed primary adenocarcinoma of the breast
- •Locally advanced or metastatic disease
- •Not amenable to surgery or radiotherapy with curative intent
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR 10 mm by CT scan
- •Not previously irradiated
- •Meets 1 of the following criteria:
- •Previously treated with anthracycline and concurrent or sequential taxane therapy
- •Refractory to the most recent taxane-based chemotherapy, defined as 1 of the following:
- •Progressive disease during therapy or within 4 months of the last dose with or without documented response for advanced disease
- •Progressive disease within 6 months of completing taxane-based chemotherapy as neoadjuvant therapy
- •Resistant to prior chemotherapy, as defined by progressive disease within 6 months of completing prior chemotherapy for advanced disease
- •No known brain metastases or carcinomatous meningitis* NOTE: *Baseline CT scan or MRI of the brain required if there is clinical suspicion of CNS metastases
- •No spinal cord compression
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •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)
- •SGOT no greater than 2.5 times ULN (5 times ULN if liver involvement secondary to tumor is present)
- •Albumin at least 3.0 g/dL
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular
- •LVEF at least 50% or ULN by echocardiogram or MUGA
- •None of the following within the past 6 months:
- •Myocardial infarction
- •Severe or unstable angina
- •Symptomatic congestive heart failure
- •Cerebrovascular accident or transient ischemic attack
- •Deep vein thrombosis or other significant thromboembolic event
- •No ongoing cardiac dysrhythmias grade 2 or greater
- •No atrial fibrillation of any grade
- •No pulmonary embolism within the past 6 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
- 另有 31 项未显示
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificGastric CancerEsophageal CancerNCT00072332Memorial Sloan Kettering Cancer Center
已完成
2 期
S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With ChemotherapyTransitional Cell Cancer of the Renal Pelvis and UreterUrethral CancerBladder CancerNCT00066612SWOG Cancer Research Network45
已完成
2 期
Docetaxel and Irinotecan in Treating Patients With Advanced Cancer of the Esophagus or StomachGastric CancerEsophageal CancerNCT00004235Alliance for Clinical Trials in Oncology47
已完成
2 期
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or SarcomaSarcomaNCT00003955Children's Oncology Group77
已完成
2 期
Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung CancerLung CancerNCT00003900Alliance for Clinical Trials in Oncology48