Status:
TERMINATED
Pre-operative Decitabine in Colon Cancer: a Proof of Principle Study
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background of the study: Colon cancer is the second leading cause of cancer-related death world wide. Although patients presenting with early disease (stage I-III) can be cured, prognosis varies from...
Detailed Description
Rationale: Colon cancer is the second leading cause of cancer-related death world wide. Although patients presenting with early disease (stage I-III) can be cured, prognosis varies from 90% in stage ...
Eligibility Criteria
Inclusion
- In- and exclusion criteria first part:
- 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:
- Inclusion criteria:
- Biopsy proven colon cancer or high suspicion of colon cancer on a previous endoscopy.
- Planned endoscopy.
- Age ≥ 18yr.
- ECOG/ WHO performance 0-2.
- Written informed consent.
- Exclusion criteria:
- 1\. Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
- In- and exclusion criteria second part:
- In order to participate in the second part of the study - treatment with decitabine - a subject must meet all of the following criteria:
- Inclusion criteriä:
- Patients with biopsy proven colon cancer who will undergo primary tumor resection.
- Age ≥ 18yr.
- ECOG/ WHO performance 0-2.
- Adequate bone marrow function (ANC\>1500/mm3, hemoglobin\>9g/dL (which may be obtained by transfusions), platelets\>100,000)
- Adequate hepatic function (AST and ALT \<2.5x upper limit of normal (ULN)).
- Adequate renal function (Serum creatinine ≤1.5 x ULN or calculated creatinine of \>50ml/min)
- 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.
- Written informed consent.
- Exclusion criteria:
- Known hypersensitivity to decitabine or its additives.
- Surgery not planned according to time frame of the study,
- Other systemic or local treatment of the primary tumor in the waiting time until surgery.
- Administration of any experimental drug within 60 days prior to the first dose of decitabine.
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01882660
Start Date
July 1 2013
End Date
January 1 2018
Last Update
December 19 2022
Active Locations (1)
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1
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ