Everest 2. A study for previously not treated patients with spread colorectal cancer characterized by the presence of wild non mutated K-Ras gene involving standard chemotherapy (FOLFIRI) and cetuximab either at standard or increased doses depending on the skin reactions determined by treatment.

Phase 1

• Conditions: K-Ras wild type metastatic colorectal cancer; MedDRA version: 16.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-009992-36-AT
• Lead Sponsor: niversity Hospital Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Written informed consent (+ optional for PK and TR) must be given according to ICH/GCP and national/local regulations.
2. Patient is at least 18 years of age.
3. Patient’s body weight is = 120 kg.
4. Histologically proven and measurable (RECIST criteria v.1.1) metastatic adenocarcinoma of the colon or rectum, not in a previously irradiated area.
5. K-Ras wild type tumour eligible for treatment with cetuximab.
6. Unresectable metastatic disease.
7. Metastatic lesion accessible for biopsy.
8. Life expectancy of at least 12 weeks.
9. WHO ECOG performance status: 0 or 1.
10. Effective contraception for both male and female patients if the risk of conception exists.
11. Adequate organ function.
12. Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry):
- Hemoglobin >10.0 g/dL, absolute neutrophil count > 1.5 x 109/L, platelet count > 100 x 109/L
- ALAT, ASAT < 2.5 x ULN, up to < 5 x ULN in case of liver metastases
- Total bilirubin < 1.5 x ULN
- Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 6 months prior to registration on study).
2. Prior treatment with EGFR inhibitor or chemotherapy with irinotecan in adjuvant settings.
3. Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry.
4. Administration of any investigational drug or agent/procedure and participation in another trial within 4 weeks before the conclusion.
5. Radiotherapy within 3 weeks before inclusion. However, radiotherapy for symptom control not on target lesions may be permitted at the condition that grade >= 2 RT related adverse events have resolved at the time of inclusion.
6. Any active dermatological condition of grade > 1.
7. Brain metastasis (known or suspected).
8. Significant impairment of intestinal absorption (e.g. chronic diarrhea, inflammatory bowel disease).
9. Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection.
10. Uncontrolled coronary artery disease and/or unstable angina, a history of a myocardial infarction within the last 12 months or heart failure NYHA class III or IV. High risk of uncontrolled arrhythmia.
11. Known allergy or any other adverse reaction to any of the drugs or to any related compound.
12. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
13. Gilbert disease.
14. Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
15. Organ allografts requiring immunosuppressive therapy.
16. Pregnancy (absence confirmed by serum/urine beta human choriongonadotrophin in pre-menopausal women) or breast-feeding.
17. Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.

Study & Design

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