Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

Study Overview
=================
Brief Summary
-----------------
A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.

Official Title
-----------------
A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: capecitabine
* Drug: irinotecan
* Drug: oxaliplatin
* Drug: cetuximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed metastatic colorectal cancer. EGF-receptor testing. No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months). No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway. No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment. Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT). Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists. Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN). Written informed consent. Exclusion Criteria: Concurrent treatment of colorectal cancer (except study medication). EGF-receptor testing not possible. Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary). Known or expected contraindication against study medication. Participation in other studies during 30 days before study entry. Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min). Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years). Known or suspected cerebral metastasis. History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis. Drug or alcohol abuse. Lack of adequate legal capacity. Breast-feeding or pregnant women. Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: irinotecan|nan|
|Drug: oxaliplatin|nan|
|Drug: cetuximab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (CR+PR) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression. |  |  | 
| Disease control rate (CR+PR+SD). |  |  | 
| Safety profile. |  |  | 
| Grade 3/4- toxicities. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capecitabine, irinotecan, cetuximab, oxaliplatin, colorectal cancer