NCT00080834已完成2 期
A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as DJ-927, 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 DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma (cancer).
详细描述
OBJECTIVES:
Primary
- Determine the objective tumor response rate in patients with progressive locally advanced or metastatic adenocarcinoma of the colon or rectum treated with DJ-927 as second-line treatment.
Secondary
- Determine the duration of response in patients treated with this drug.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival time in patients treated with this drug.
- Determine the quantitative and qualitative toxic effects 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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the colon or rectum
- •Progressive locally advanced or metastatic disease
- •Received 1 prior irinotecan- or oxaliplatin-containing regimen
- •At least 1 measurable lesion
- •Target lesion must be outside field of prior radiotherapy
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •ALT and AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Gastrointestinal
- •No difficulty with swallowing
- •No malabsorption
- •No diarrhea (excess of 2-3 stools/day above normal frequency) within the past month
- •No history of chronic diarrhea
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No concurrent serious infection
- •No other concurrent severe or uncontrolled underlying medical condition that would preclude study participation
- •No neuropathy ≥ grade 2
- •No history of any severe or life-threatening hypersensitivity reaction
- •No psychiatric disorder that would preclude study compliance
- •No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent biologic therapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior myelosuppressive chemotherapy and recovered
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •Localized radiotherapy to non-indicator lesions for pain relief allowed provided other methods of pain control are ineffective
- •At least 4 weeks since prior major surgery and recovered
- •No prior major surgery in the stomach or small intestine
- •More than 28 days since prior investigational agents (including analgesics and/or antiemetics)
- 另有 3 项未显示
排除标准
- 未提供
研究者
研究点 (4)
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