NCT00470405已完成1 期
A Phase I Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Pemetrexed may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and the recommended phase II dose of pemetrexed disodium in combination with oxaliplatin in patients with metastatic solid tumors or lymphoma.
Secondary
- Determine the quantitative and qualitative toxicities of this regimen in these patients.
- Determine, preliminarily, the efficacy of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Pathologic or cytologic diagnosis of solid tumors or lymphoma
- •Metastatic disease
- •No curative or effective therapy exists
- •Measurable or nonmeasurable disease
- •No clinically relevant third-space fluid collections
- •Fluid collections must be drained before study enrollment
- •No leukemia
- •No CNS metastases
排除标准
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 3.0 times ULN (5 times ULN if liver has tumor involvement)
- •Creatinine clearance ≥ 45 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •No active infection or other serious illness that would preclude study participation
- •No weight loss ≥ 10% within the past 6 weeks
- •No peripheral neuropathy (e.g., diabetic neuropathy) ≥ CTC grade 1
- •Must be able to take concurrent vitamin B12 and folic acid
- •PRIOR CONCURRENT THERAPY:
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •More than 12 months since prior adjuvant therapy
- •More than 30 days since prior drug that has not received regulatory approval
- •More than 30 days since prior radiation therapy and recovered (alopecia allowed)
- •Prior standard postoperative adjuvant radiation therapy for rectal cancer allowed
- •No prior radiation therapy to ≥ 25% of bone marrow
- •No prior oxaliplatin or pemetrexed disodium
- •No NSAIDs or acetylsalicylic acid 2 days before (5 days for long-acting agents [e.g., piroxicam]), during, and for 2 days after each dose of pemetrexed disodium
- •No concurrent nonpalliative radiation therapy or surgery for cancer
- •No concurrent hormonal cancer therapy (except medroxyprogesterone)
- •No other concurrent experimental medications (except thymidine)
- •No other concurrent chemotherapy or immunotherapy
- •No other concurrent anticancer therapy
- •Concurrent palliative radiation therapy allowed for small areas of painful metastasis that cannot be managed adequately by systemic or local analgesics
研究组 & 干预措施
Therapeutic Intervention
Experimental
干预措施: oxaliplatin (Drug)
Therapeutic Intervention
Experimental
干预措施: pemetrexed disodium (Drug)
结局指标
主要结局
Maximum tolerated dose
Recommended phase II dose
次要结局
- Toxicity
- Efficacy
研究者
研究点 (1)
Loading locations...
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