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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan; Drug: FOLFOX 6; Drug: FOLFIRI

• Registration Number: NCT00286130
• Lead Sponsor: Central European Cooperative Oncology Group

Brief 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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-02-02
• Study First Submitted QC: 2006-02-02
• Study First Posted: 2006-02-03
• Study Completion: 2007-10
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-30
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFOX 6	Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan	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:
FOLFOX 6	FOLFOX 6	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:
FOLFIRI	Cetuximab, Oxaliplatin, Leucovorin, 5FU, Irinotecan	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
FOLFIRI	FOLFIRI	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

Primary Outcome Measures

Name	Time	Method
the percentage of patients surviving without disease progression in each arm at 9 months

Secondary Outcome Measures

Name	Time	Method
PFS rates at 3,6,12 months
Response rates
Overall survival (OS) in each arm
Safety

Trial Locations

Locations (26)

University Hospital Rebro; 🇭🇷 Zagreb, Croatia

Souraski Medical Center; 🇮🇱 Tel Aviv, Israel

University Hospital for Tumors; 🇭🇷 Zagreb, Croatia

Hospital Amadora Sintra, Servico de Oncologia; 🇵🇹 Amadora, Portugal

Univ. Hospital Brno, Dept. Of Clinical Oncology; 🇨🇿 Brno, Czech Republic

Bank of Cyprus Oncology Center; 🇨🇾 Nikosia, Cyprus

Institute of Oncology; 🇸🇮 Ljubljana, Slovenia

University Hospital "Queen Joanna"; 🇧🇬 Sofia, Bulgaria

SBALO National Oncology Center; 🇧🇬 Sofia, Bulgaria

National Medical Center; 🇭🇺 Budapest, Hungary

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Markusovsy Hospital; 🇭🇺 Szomathely, Hungary

Csolnoky Ferenc County Hospital; 🇭🇺 Veszprem, Hungary

Hospital de Beja; 🇵🇹 Beja, Portugal

Hospital Distrital de Faro; 🇵🇹 Faro, Portugal

Institutul Oncologic Cluj; 🇷🇴 Cluj-Napoca, Romania

Ankara Hacettepe University, Oncology Unit; 🇹🇷 Ankara, Turkey

National Cancer Institute; 🇸🇰 Bratislava, Slovakia

Gazi University Medical Faculty; 🇹🇷 Ankara, Turkey

9 Eyul University Medical Faculty, Dep of Oncology; 🇹🇷 Izmir, Turkey

Univ. Klinik für Innere Medizin I; 🇦🇹 Wien, Austria

Hospital San Teotóno -; 🇵🇹 Viseu, Portugal

Charles University Prague, Dep. of Oncology; 🇨🇿 Prague, Czech Republic

LKH Leoben, Abt. für Innere Medizin; 🇦🇹 Leoben, Steiermark, Austria

Hospital Geral de Sto. António; 🇵🇹 Porto, Portugal

Institutul Oncologic Bucuresti; 🇷🇴 Bucuresti, Romania