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

Central European Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: FOLFIRI; Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan; Drug: FOLFOX 6

Study type: Interventional

Funder types: Other

Identifiers

NCT00286130

CECOG/Core 1.2.001

EUDRACT number 2004-002391-42

Details and patient eligibility

About

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

Full description

The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.

EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.

Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

FOLFOX 6

Active Comparator group

Description:

FOLFOX 6: * Oxaliplatin 100 mg/m² d1 concurrent with * Leucovorin 400 mg/m², followed by * Bolus 5FU 400 mg/m² , followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks:

Treatment:

Drug: FOLFOX 6

Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan

FOLFIRI

Active Comparator group

Description:

FOLFIRI: * Irinotecan 180 mg/m² day 1 concurrent with * Leucovorin 400 mg/m² followed by * Bolus 5FU 400 mg/m², followed by * Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks

Treatment:

Drug: FOLFIRI

Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan