Pre-operative Decitabine in colon cancer: a proof of principal study (DECO)

Phase 1

• Conditions: colon cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001060-38-NL
• Lead Sponsor: Academic Medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-16
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

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 <2.5x upper limit of normal (ULN)).
6. Adequate renal function (Serum creatinine =1.5 x ULN or calculated creatinine of >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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified