A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX4 + weekly Cetuximab versus FOLFOX4 + bi-weekly Cetuximab as first-line therapy in patients with K-ras wild type metastatic colorectal cancer

CECOG (Central European Cooperative Oncology Group)0 sites150 target enrollmentSeptember 20, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: first-line therapy in patients with K-ras wild type metastatic colorectal cancer
Sponsor: CECOG (Central European Cooperative Oncology Group)
Enrollment: 150
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

September 20, 2007

End Date

TBD

Last Updated

12 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 at least 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 for K\-ras and EGFR assessment; K\-ras has to be assessed as wild\-type by a central laboratory
•Presence of at least one lesion measurable unidimensionally by CT scan or MRI (target lesion(s) must not lie within an irradiated area)
•Karnofsky performance status of \> 80 at study entry
•Leucocytes at least 3\.0 x 109/L and neutrophils at least 1\.5 x 109/L, platelets at least 100 x 109/L, and hemoglobin at least 9 g/dL
•Bilirubin not exceeding 1\.5 x ULN
•ASAT and ALAT not exceeding 2\.5 x ULN (not exceeding 5 x ULN if liver metastasis are present)

•Brain metastasis (known or suspected)
•Previous chemotherapy for metastatic disease. Prior adjuvant chemotherapy 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\. In case of prior oxaliplatin containing adjuvant chemotherapy: pre\-existing neuropathy of grade 1 or higher.
•Known grade 3 or 4 allergic reaction to any of the components of the treatment.