colon cancer
Conditions
Interventions
Trade Name: Dacogen
Product Name: Dacogen
Pharmaceutical Form: Infusion
Sponsors
Academic Medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in the first part of the study, five extra fresh biopsies to determine tumor methylation status, a subject must meet all of the following criteria: 1. Biopsy proven colon cancer or high suspicion of colon cancer on a previous endoscopy. 2. Planned endoscopy. 3. Age = 18yr. 4. ECOG/ WHO performance 0-2. 5. Written informed consent. In order to participate in the second part of the study - treatment with decitabine - a subject must meet all of the following criteria: 1. Patients with biopsy proven colon cancer who will undergo primary tumor resection. 2. Age = 18yr. 3. ECOG/ WHO performance 0-2. 4. Adequate bone marrow function (ANC>1500/mm3, hemoglobin>9g/dL (which may be obtained by transfusions), platelets>100,000) 5. Adequate hepatic function (AST and ALT 50ml/min) 7. Women of child-bearing age must be willing to use adequate contraception and have negative serum or urine pregnancy test within 3 days prior to registration. 8. Written informed consent. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: A potential subject for the first part of the study - extra biopsies to determine tumor methylation status - who meets any of the following criteria will be excluded from participation in this study: 1. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol. A potential subject for the second part of the study - treatment with decitabine - who meets any of the following criteria will be excluded from participation in this study: 1. Known hypersensitivity to decitabine. 2. Surgery not planned according to time frame of the study, 3. Other systemic or local treatment of the primary tumor in the waiting time until surgery. 4. Administration of any experimental drug within 60 days prior to the first dose of decitabine. 5. Women of child-bearing age who are pregnant or lactating. 6. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment biopsies.;Secondary Objective: To assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can revert CpG methylation and induce more favorable tumor characteristics as measured in resected tumors compared to pretreatment biopsies;Primary end point(s): Wnt target gene expression (APCDD1, AXIN2, DKK1, LGR5 and ASCL2). ;Timepoint(s) of evaluation of this end point: After surgery of colon cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Wnt target and CIMP gene methylation, ?-catenin localization, proliferation (Ki-67), apoptosis (TUNEL and M30 assay) and tumor differentation.;Timepoint(s) of evaluation of this end point: After surgery of colon cancer | — |
Countries
Netherlands
Contacts
Public ContactLyda ter Hofstede
Academic Medical Center
Outcome results
None listed