A Phase I Study of a Combination of High Selenium Brassica Juncea With Irinotecan and Capecitabine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Pharmacokinetics
研究概览
简要总结
RATIONALE: Brassica juncea that contains high amounts of selenium may slow the growth of cancer cells. Drugs used in chemotherapy, such as irinotecan and capecitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-selenium Brassica juncea together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of high-selenium Brassica juncea and capecitabine when given together with irinotecan in treating patients with advanced cancer.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of high-selenium Brassica juncea (BJ-Se) and capecitabine when administered in combination with irinotecan hydrochloride in patients with advanced malignancies.
- To determine the effects of BJ-Se on the pharmacokinetics of irinotecan hydrochloride and capecitabine.
Secondary
- To determine the effect of BJ-Se on the serum selenium and protein profile.
- To correlate response and tolerance to this regimen with expression of key enzymes involved as targets or with the metabolism of the components of treatment, including thymidylate synthase and dihydropyrimidine dehydrogenase.
- To evaluate changes to potential selenium related parameters.
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
- •Patients with advanced, biopsy-proven cancer for which there is no standard curative therapy
- •Karnofsky Performance status >= 60
- •Prior therapy completed at least 3 weeks before protocol treatment initiation with recovery from any side-effects
- •Prior capecitabine and/or irinotecan are allowed if subject did not progress while on treatment or within 6 months of treatment with these medications either alone or in combination
- •Prior radiation therapy allowed if < 30% of marrow treated
- •Alanine aminotransferase (ALT) and alkaline phosphatase with 3x upper limit of normal
- •Serum bilirubin within normal limits
- •Absolute neutrophil count >= 15000/ul
- •Platelet count >= 100,000/ul
- •Hemoglobin >= 10 gm/dl - transfusion allowed to achieve this
- •Serum creatinine within 1.5 x upper limit of normal
- •Ability to understand and sign an IRB approved informed consent
- •Ability to use appropriate contraception and no evidence of pregnancy in female patients of reproductive potential
排除标准
- •No significant medical or psychiatric condition that would make treatment unsafe
- •No active brain metastases (patients who have treated brain metastases and are stable off of steroids are eligible)
- •Nursing women
- •Patients must be able to comply with protocol related studies and follow-up
- •Patients who are UGT1a1 7/7 positive will be excluded from the dose escalation portion of the trial, but may participate in the cohort of patients treated at the MTD
研究组 & 干预措施
Treatment (high-selenium therapy and chemotherapy)
干预措施: high-selenium Brassica juncea (Dietary Supplement)
Treatment (high-selenium therapy and chemotherapy)
干预措施: capecitabine (Drug)
Treatment (high-selenium therapy and chemotherapy)
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: For patients treated at the MTD only at the end of cycle one of treatment
Maximum tolerated dose of high-selenium Brassica juncea, irinotecan hydrochloride and capecitabine
时间窗: After two 21 day cycles of treatment
Toxicity
时间窗: After two 21 day cycles of treatment
次要结局
- Serum selenium and protein profile(21 days after the start of the last cycle of treatment)