Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.

The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central European Cooperative Oncology Group
• Treatments: Cetuximab; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• 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 unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)

• ECOG performance status of < 2 at study entry

Exclusion Criteria:

• 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 irritation within 4 weeks prior to study entry

• Cocurrent 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