A Single-blind, Randomized Phase I/II study of Pharmacokinetic and Pharmacodynamic investigation of Modufolin® (60 or 200 mg/m2) compared to Levoleucovorin (60 or 200 mg/m2) in tumour, adjacent mucosa and plasma for patients with colon cancer. - PK/PD study of Modufolin® in plasma, tumour and adjacent mucosa in patients with colon cance

Isofol Medical AB0 个研究点开始时间: 2012年2月8日最近更新: 2014年8月11日

适应症

试验速览

暂无简介。

•1.Patients must have operable colon cancer that is amenable to curative surgery.
•2.Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG). Performance Status scale. (See Protocol Attachment 2.)
•3.Patients without contra indications for undergoing surgery.
•4.For women: Must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after treatment; must have a negative serum or urine pregnancy test (within 7 days before enrolment) and must not be lactating.
•5.For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.
•6.Patients must sign an informed consent document.
•7.Patient legally competent and able to communicate effectively with the study personnel as judged by the investigator.
•8.Patient likely to co-operate during the study.
•9.Patients must be at least 18 years of age.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 26
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 38

•1.Concurrent administration of any other anti-tumor therapy.
•2.Treatment within the last 30 days with a drug/device that has not received regulatory approval for any indication at the time of study entry.
•3.Any intake of medication which could influence homocysteine, folate, and vitamin B12 status, within 30 days of surgery
•4.Serious concomitant systemic disorders (e.g., active infection including HIV, cardiac disease) that in the opinion of the investigator would compromise the patient's ability to complete the study.
•5.Are pregnant or breast-feeding.
•6.Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
•7.History of significant neurological or mental disorder, including seizures or dementia.
•8.Presence of clinically relevant (i.e., detectable by physical examination) third-space fluid collection (e.g., ascites, pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry.
•9.Inability or unwillingness to be given Modufolin® or Levoleucovorin (Isovorin®).

发起方