Phase II study of therapy with Cetuximab and Irinotecan every second week to Irinotecan resistant patients with metastatic colorectal cancer-effect and biological markers

• Conditions: In Denmark there is approximately 3600 new cases of Colorectal cancer every year. In Denmark about half of these patients will eventually develop metastatic disease. In Denmark it is suggested that 150 patients each year will be in such good performance to third line chemotherapy.; MedDRA version: 9Level: 1.0Classification code 10010029

• Registration Number: EUCTR2006-001961-40-DK
• Lead Sponsor: Department of Oncology, University Hospital Herlev

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patient with histological proven MCRC.
2.Patients must have measurable disease, according to RECIST criteria.
3.Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter.
4.Age =18 years.
5.Performance status (WHO) of 0-2.
6.Patient must have a life expectancy of at least 3 months.
7.Adequate hematological function defined ANC ³1.5 x 109/l 1.Patient with histological proven MCRC.
2.Patients must have measurable disease, according to RECIST criteria.
3.Irinotecan resistant disease i.e. progressive disease after at least 6 weeks of therapy with Irinotecan-containing therapy or within 3 months thereafter.
4.Age =?18 years.
5.Performance status (WHO) of 0-2.
6.Patient must have a life expectancy of at least 3 months.
7.Adequate hematological function defined ANC ³1.5 x 109/l and platelets =100 x 109/l .
8.Adequate liver function defined as Bilirubin = 1,5 x UNL (upper normal limit) and/or ASAT/ALAT = 5 x UNL.
9.All should have been exposed to Oxaliplatin-containing therapy.
10.Written informed consent must be obtained according to the local Ethics Committee requirements.
platelets 100 x 109/l .
8.Adequate liver function defined as Bilirubin = 1,5 x UNL (upper normal limit) and/or ASAT/ALAT = 5 x UNL.
9.All should have been exposed to Oxaliplatin-containing therapy.
10.Written informed consent must be obtained according to the local Ethics Committee requirements.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous or some other concomitant malignancy, with the exception of adequately treated basal cell skin cancer or in situ cervical cancer.
2.Inability to follow the treatment and evaluation schedule.
3.Any other condition or therapy which in the investigator’s opinion may pose a risk to the patient or interfere with the study objectives.
4.Pregnant or lactating women. In fertile women this is ensured by a negative pregnancy test or use of safe antikonception (as defined by the Danish medicines agency during the study period and at least 3 months thereafter.
5.Patients with active infections or other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment.
6.Known hypersensitivity to any of the components of the treatment.
7.Legal incapacity.
8.Reduced liver function defined by bilirubin > 5 x UNL or ASAT/ALAT > 5xUNL

Study & Design

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