NCT00081107已完成2 期
A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease
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 epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy.
Secondary
- Determine the safety of this drug in these patients.
- Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug.
- Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment.
- Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites 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:
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IIIB* or IV disease NOTE: *Due to malignant pleural effusion or supraclavicular lymph node involvement only
- •Previously treated with maximally feasible surgical resection and/or radiotherapy for initial disease
- •Failed 1 prior platinum-containing chemotherapy regimen for advanced or metastatic disease due to disease progression or treatment toxicity
- •At least 1 site of unidimensionally measurable disease by physical exam or radiography
- •No known CNS metastases or leptomeningeal metastases requiring corticosteroids
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Hemoglobin ≥ 8 g/dL
- •Platelet count ≥ 75,000/mm^3
- •AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with hepatic metastases)
- •Alkaline phosphatase ≤ 5 times ULN
- •Bilirubin ≤ 1.8 mg/dL
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •No New York Heart Association class III or IV congestive heart failure
- •No personal or family history of congenital long QT syndrome
- •No QTc interval > 450 msec (males) or > 470 msec (females) by ECG
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No preexisting neuropathy ≥ grade 2
- •No other malignancy within the past 5 years except for the following:
- •Cured basal cell skin cancer
- •Carcinoma in situ of the cervix or urinary bladder
- •Stage T1 or T2 prostate cancer with prostate-specific antigen < 2 ng/mL
- •No hypersensitivity reaction ≥ grade 3 to prior Cremophor-containing therapy
- •No infection requiring parenteral or oral anti-infective therapy
- •No weight loss of ≥ 10% within the past 3 months
- •No altered mental status or psychiatric illness that would preclude giving informed consent
- •No other medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent granulocyte-macrophage colony-stimulating factor (sargramostim [GM-CSF])
- •No concurrent routine prophylactic granulocyte colony-stimulating factor (filgrastim [G-CSF])
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy and recovered
- •Endocrine therapy
- •See Disease Characteristics
- •Radiotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •See Disease Characteristics
- 另有 7 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
2 期
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal CancerColorectal CancerNCT00077259Memorial Sloan Kettering Cancer Center
已完成
2 期
BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With ChemotherapyGastric CancerEsophageal CancerNCT00017043Bristol-Myers Squibb
终止
2 期
BMS-247550 in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00033306University of Alabama at Birmingham2
已完成
2 期
BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With ChemotherapyGastric CancerEsophageal CancerNCT00017056Memorial Sloan Kettering Cancer Center
已完成
2 期
BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal CancerColorectal CancerNCT00022477University of Chicago24