A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX6 + Cetuximab versus FOLFIRI + Cetuximab as first-line therapy in patients with metastatic colorectal cancer

CECOG (Central European Cooperative Oncology Group)0 sites150 target enrollmentMarch 30, 2005

Overview

No summary available.

Registry

who.int

Start Date

March 30, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CECOG (Central European Cooperative Oncology Group)

•Signed written informed consent
•Male or female more or equal 18 years of age
•Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
•Metastatic colorectal carcinoma not suitable for curative\-intent resection
•Availability of tumor sample (or able and willing to provide tumor sample)
•for EGFR assessment
•Presence of at least one lesion measurable unidimensionally by CT scan or MRI. (Target lesion(s) must not lie within an irradiated area)
•ECOG performance status less than 2
•White blood cell count more or equal 3\.0 x 109/L with neutrophils more or equal 1\.5 x 109/L, platelet count more or equal 100 x 109/L, and hemoglobin more or equal 9 g/dL.
•Bilirubin level either normal or less or equal 1\.5 x ULN

•Brain metastasis (known or suspected)
•Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months.
•Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry
•Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
•Any investigational agent(s) within 4 weeks prior to entry
•Previous exposure to EGFR\-pathway targeting therapy
•Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
•Acute or subacute intestinal occlusion or history of inflammatory bowel disease
•Pre\-existing neuropathy \> grade 1
•Known grade 3 or 4 allergic reaction to any of the components of the treatment.