Medical treatment of patients with cancer in colon or rectum

Phase 1

Conditions: Patients with refractory colorectal cancer
MedDRA version: 16.1Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 16.1Level: HLTClassification code 10010023Term: Colorectal neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Registration Number: EUCTR2012-002327-15-DK

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Patients with histologically proven non-resectable adenocarcinoma of the colon or rectum.
2. Patients who progress and who have been previously treated with fluoropyrimine, irinotecan, oxaliplatin and cetuximab (if K-RAS wild type).
3. Age = 18 years old.
4. Performance status (WHO) 0-1.
5. Adequate bone-, liver and kidney function: hemoglobin > 6,0 µmol/l, neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/l, bilirubin = 1,5 x UNL (Upper Normal Limit), ALAT or ASAT = 5 x UNL, creatinine = 1,5 xUNL, PP % between 0.5 - 1.3, APTT < 1.5 x UNL.
6. Signed consent form.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Cytotoxic treatment or other experimental treatment within 2 weeks of inclusion.
8. Other serious disease (ie. heartdisease, AMI within 1 year or ongoing infection).
9. Patients who cannot follow treatment schedule or evaluation schedule.
10. Known hypersensitivity towards one of the study drugs.
11. Any condition or therapy which after the decision of the investigator can put the patient on risk or affect the end-points of the study.
12. Pregnant women or women who are lactating. Patients who are not using contraception.