Colon cancer MedDRA version: 16.0 Level: PT Classification code 10009944 Term: Colon cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Isofol Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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®).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): An exploratory evaluation of the tumor and mucosa concentrations of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF will be done respectively for comparisons between treatments. ;Timepoint(s) of evaluation of this end point: At the time of biopsy;Main Objective: • To compare [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF concentration in the tumor tissue and adjacent mucosa for the different treatment groups;Secondary Objective: • To explore if there is a difference in other pharmacokinetic parameters of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF calculated from plasma concentration. • To study safety in terms of adverse events and laboratory measurements; haematology, clinical chemistry and urinalysis. • To study gene expression in tumor and mucosa and its correlation to tissue concentration. • To study homocystein and serum folate levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): An exploratory evaluation of the pharmacokinetic parameters of [6R] 5,10-methylene-THF, 5-formyl-THF, 5-methyl-THF and THF will be done respectively for comparisons between treatments. Correlation between AUC(0-2h) calculated from plasma concentration and tissue concentration in the tumor and adjacent mucosa will be explored. Change over time in homocystein and serum folate levels will be explored. Gene expression in tumor and mucosa and correlation to tissue concentration will be explored. Assessment of safety will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. electrocardiogram, vital signs) will be considered as appropriate.;Timepoint(s) of evaluation of this end point: PK: t = 0, 5 min, 10 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min, 240 min, 360 min, and 24 h Homocystein and serum folate: t = screening, t = 24 h and t = 5 days (end of study visit) Correlation between plasma and tissue concentration: 0 - 2 h Biopsies for studying gene expression in tumor and mucosa will be collected during surgery. Safety assessments will start at t = 0 and continue througout the study (incl. 5 days post surgery). | — |
Countries
Sweden
Contacts
Public ContactPrincipal Investigator
Sahlgrenska University Hospital
Outcome results
None listed