A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)
研究概览
简要总结
This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.
详细描述
This study is a Phase I trial. A total of 3 - 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled 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
- •Patients with 3rd line or > metastatic colon cancer
- •Patients must have received or not be candidates for regimens containing 5- FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab
- •No prior exposure to perifosine
- •Adequate bone marrow, liver, and renal function
- •Patients must have at least one measurable lesion
- •Patients must agree to have extra blood drawn for PK analyses
排除标准
- •Patients with prior exposure to perifosine.
- •Patients receiving any other investigational agents or devices.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
- •Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU.
- •Patients with known central nervous system CNS metastases.
- •Patients with known HIV, Hepatitis B, or Hepatitis C seropositivity.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II-IV congestive heart failure.
- •Female patients who are pregnant or lactating are ineligible.
研究组 & 干预措施
Perifosine +Capecitabine
One cycle of therapy will be defined as 3 weeks (21 days). Perifosine 50 mg qd (Days 1-21) + Capecitabine 1000 mg/m2 BID (Days 1-14).
干预措施: Perifosine (Drug)
Perifosine +Capecitabine
One cycle of therapy will be defined as 3 weeks (21 days). Perifosine 50 mg qd (Days 1-21) + Capecitabine 1000 mg/m2 BID (Days 1-14).
干预措施: Capecitabine (Drug)
结局指标
主要结局
Safety and tolerability of the combination of perifosine and capecitabine (i.e., dose limiting toxicity)
时间窗: Every 3 weeks after dosing
The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. A DLT will be defined as any of the following deemed to be related to study drug(s): * Grade 3 non-hematologic toxicity except alopecia not reversible to Grade 2 or less within 96 hours * Any Grade 4 toxicity DLT will be based on the first cycle of treatment (first 21 days). Toxicity will be graded according to the NCI CTCAE version 3.0. To be evaluable for toxicity, a patient must receive at least 1 complete course of treatment or have experienced DLT.
次要结局
- Time to progression(Every 3 cycles after dosing (length of one cycle is 21 days))
- Pharmacokinetic (PK) data for the combination of perifosine and capecitabine(Up to cyle 5 no pharmacokinetic samples were obtained. Cycle 1/Day 11 until Cycle 4/Day 11: pharmacokinetic samples obtained 0.5, 1, 2, 4, 6 and 8 hours after dosing)
- Best overall response(Every 3 cycles after dosing (length of one cycle is 21 days))