A Single-blind, Randomized Phase I/II Study of Pharmacokinetic and Pharmacodynamic Investigation of Modufolin® Compared to Levoleucovorin in Tumor, Adjacent Mucosa and Plasma for Patients With Colon Cancer
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).
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
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.
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
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®).