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

Ludwig Maximilian University of Munich

Status and phase

Completed

Phase 2

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: cetuximab

Drug: capecitabine

Drug: irinotecan

Drug: oxaliplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00254137

CRC-02-2004

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.