Phase Fase II examination of irinotecan, cetuximab and everolimus for patients resistente to chemoptherapy with metastatic colorectal cancer and KRAS mutation or with KRAS wildtype after progression on therapy with irinotecan og cetuximab – effect and biological markers. - ICE

Phase 1

• Conditions: Patient with metastatic colorectal cancer; MedDRA version: 12.0Level: LLTClassification code 10010029Term: Colorectal cancer NOS

• Registration Number: EUCTR2009-015952-11-DK
• Lead Sponsor: Department of OncologyHerlev University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-28
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

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

Inclusion Criteria

Criteria for inclusion:
1.Patients with a histological or cytological verified adenocarcinoma of the colon or rectum with non-resectable or metastatic cancer.
2.Patients with measurable disease without previous radiotherapy according to RECIST criteria.
3.Patients with metastatic colorectal cancer with progression after previous therapy with 5-fluoropyrimidiner, oxaliplatin or irinotecan. Patients should have been treated with oxaliplatin, but if oxaliplatin has be contraindicated or not tolerated the patient can participate in the trial.
4.Patients with KRAS mutation in their primary tumour or metastasis.
5.Patients with progression after therpay with irinotecan or cetuximab undependent of KRAS mutation status. .
6.Previous radiotherapy is allowed to less than 25 % of the bone marrow.
7.Age more or equal to 18 years.
8.Performance status (WHO) less than 3.
9.An expected survival time of at least 3 months.
10.Absolute Neutrophil Count (ANC) ?1,5 x 109/l and trombocyt count =100 x 109/l.
11.Normal liver function with bilirubin =1,5 x UNL (upper normal limit) og ASAT/ALAT < 5 x UNL. No UNL for ASAT/ALAT is required in patients with livermetastasis.
12.Signed informed consent according to specifications from the ethical comitees.

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

Criterai for exclusion:
1.Former or other concurrent malignant disease exept treated basal cell carcinoma or in situ cervical cancer.
2.No cytotoxic therapy or other experimental treatment within 28 days before inclusion.
3.No former therapy with everolimus or other rapamyciner (sirolimus, temsirolimus).
4.No known hypersensitivity for one or more components in the therapy.
5.No uncontrolled diabetes defined as a fasting blod sucker > 1.5 x ULN (upper normal limit).
6.No serious non-healing wounds, gastic ulcers, bonefractures, greater surgical procedures, major traumatic injuries within 28 days before inclusion.
7.No ungoing bleading or pathological condition associated with a risk of bleading.
8.No liverdisease as cirrhose, chronical active hepatitis or chronic persistent hepatitis.
9.No gastrointestinal disturbences in function that might cause a major change in the absortion of everolimus as ulcerative disease, ucontrolled nausea, vomiting, diarrhoe, malabsorption syndrom.
10.No planned immunisation with attenuated virus in the study period.
11.Patients thjat is unable to follow treatment or evaluation plan.
12.Every condition or therapy that after the judgement of investigator might infer the patient a risk or influence the trials objective.
13.Pregnant or breastfeeding women. At fertile women this is insured by a negative test of pregnancy or use of a safe antikonception during the trial period and at least 3 months after end of treatment.
14.Patients with active infections or other serious medical co-morbidity, that might prevent the patient from being treated with the protocoled therapy.
15.Incapacitated,

Study & Design

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