NCT00019773已完成1 期
Pilot Study of Oxaliplatin in Combination With Capecitabine in Adult Cancer Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have colorectal, appendix, or small bowel cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of capecitabine when administered with oxaliplatin in patients with colorectal, appendiceal, or small bowel cancer.
- Determine the clinical toxic effects associated with this regimen in these patients.
- Characterize the molecular profile of tumor tissue obtained prior to study entry for determinants of sensitivity to this regimen in this patient population.
- Characterize the molecular profile of a surrogate normal tissue (bone marrow aspirate) obtained prior to treatment and assess any potential drug-associated induction of DNA damage and inhibition of thymidylate synthase with a repeat bone marrow aspirate during therapy.
- Assess any clinical activity of this regimen in this patient population.
OUTLINE: This is a dose-escalation study of capecitabine.
Patients receive oxaliplatin IV over 2 hours on day 1 followed by oral capecitabine twice daily on days 1-5 and 8-12. Courses repeat every 3 weeks in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 colorectal, appendiceal, or small bowel cancer
- •Measurable disease
- •No progression after prior capecitabine
- •No brain metastases or leptomeningeal carcinomatosis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal
- •Creatinine clearance greater than 60 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 sensory neuropathy
- •No history of allergy to platinum compounds
- •No history of allergy to antiemetics appropriate for administration during study
- •No history of intolerance to fluorouracil
- •No uncontrolled concurrent illness that would preclude study entry
- •No ongoing or active infection requiring IV antibiotics
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy:
- •See Disease Characteristics
- •Recovered from prior chemotherapy
- •No more than 2 prior systemic chemotherapy regimens for metastatic disease
- •At least 6 weeks since prior nitrosoureas or mitomycin
- •At least 8 weeks since prior eniluracil
- •At least 3 months since prior suramin
- •At least 4 weeks since other prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Recovered from prior radiotherapy
- •At least 2 weeks since prior radiotherapy to no more than 20% of bone marrow reserve
- •At least 4 weeks since prior radiotherapy to at least 21% of bone marrow reserve
- •Recovered from prior surgery
- 另有 4 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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