NCT00077259已完成2 期
A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC)
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 as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of epothilone D as second-line treatment, in terms of objective response rate, in patients with advanced or metastatic refractory colorectal cancer.
Secondary
- Determine the safety of this drug in these patients.
- Determine the response duration in patients responding to treatment with this drug.
- Determine time to tumor progression and overall survival in patients treated with this drug.
- 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 advanced or metastatic adenocarcinoma of the colon or rectum
- •Evidence of at least 1 site of unidimensionally measurable disease by radiography or physical examination
- •Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan OR oxaliplatin for advanced or metastatic disease
- •No known CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hemoglobin ≥ 9 g/dL
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
- •Alkaline phosphatase ≤ 5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No New York Heart Association class III or IV congestive heart failure
- •No QTc > 450 msec for males or > 470 msec for females
- •No personal or family history of congenital long QT syndrome
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception
- •No pre-existing neuropathy grade 2 or greater
- •No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor
- •No infection requiring parenteral or oral anti-infective treatment
- •No altered mental status or psychiatric condition that would preclude giving informed consent
- •No other medical condition that would preclude study participation
- •No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a prostate-specific antigen < 2 ng/mL
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent sargramostim (GM-CSF)
- •No concurrent routine prophylactic use of filgrastim (G-CSF)
- •Chemotherapy
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy and recovered
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy and recovered
- •At least 3 weeks since prior surgery and recovered
- •More than 3 weeks since prior investigational agents (therapeutic or diagnostic)
- •No other concurrent therapy for advanced or metastatic colorectal cancer
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (1)
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