NCT00052507已完成2 期
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal 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
- 4
研究概览
简要总结
RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and response duration in patients treated with this drug.
- Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.
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 adenocarcinoma of the colon or rectum that is incurable with conventional therapy
- •Metastatic or recurrent disease
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
- •Disease must be accessible to biopsy
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-1 OR
- •Karnofsky 70-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- •AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases present)
- •Creatinine no greater than 1.25 times UNL OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled concurrent illness
- •No ongoing or active infection
- •No other active malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No grade 1 or greater peripheral neuropathy due to prior chemotherapy
- •No significant traumatic injury within the past 21 days
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No more than 1 line of prior chemotherapy (including any combination of fluorouracil, irinotecan, and/or oxaliplatin) for metastatic disease
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Prior adjuvant chemotherapy allowed
- •No concurrent cytotoxic chemotherapy
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to measurable target lesion unless disease progression has occurred after radiotherapy
- •No concurrent radiotherapy to the sole site of measurable disease
- •More than 21 days since prior major surgery
- •No other concurrent investigational agents
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究者
研究点 (4)
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