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

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286130
• Other study ID #: CECOG/Core 1.2.001
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2006
• Last updated: April 30, 2012
• Start date: July 2005
• Est. completion date: October 2007

Study information

• Verified date: April 2012
• Source: Central European Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

• 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
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

Locations

Country	Name	City	State
Austria	LKH Leoben, Abt. für Innere Medizin	Leoben	Steiermark
Austria	Univ. Klinik für Innere Medizin I	Wien
Bosnia and Herzegovina	Institute of Oncology	Sarajevo
Bulgaria	SBALO National Oncology Center	Sofia
Bulgaria	University Hospital "Queen Joanna"	Sofia
Croatia	University Hospital for Tumors	Zagreb
Croatia	University Hospital Rebro	Zagreb
Cyprus	Bank of Cyprus Oncology Center	Nikosia
Czech Republic	Univ. Hospital Brno, Dept. Of Clinical Oncology	Brno
Czech Republic	Charles University Prague, Dep. of Oncology	Prague
Hungary	National Medical Center	Budapest
Hungary	Markusovsy Hospital	Szomathely
Hungary	Csolnoky Ferenc County Hospital	Veszprem
Israel	Hadassah Medical Center	Jerusalem
Israel	Souraski Medical Center	Tel Aviv
Portugal	Hospital Amadora Sintra, Servico de Oncologia	Amadora
Portugal	Hospital de Beja	Beja
Portugal	Hospital Distrital de Faro	Faro
Portugal	Hospital Geral de Sto. António	Porto
Portugal	Hospital San Teotóno -	Viseu
Romania	Institutul Oncologic Bucuresti	Bucuresti
Romania	Institutul Oncologic Cluj	Cluj-Napoca
Slovakia	National Cancer Institute	Bratislava
Slovenia	Institute of Oncology	Ljubljana
Turkey	Ankara Hacettepe University, Oncology Unit	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	9 Eyul University Medical Faculty, Dep of Oncology	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Central European Cooperative Oncology Group

Countries where clinical trial is conducted

Austria,  Bosnia and Herzegovina,  Bulgaria,  Croatia,  Cyprus,  Czech Republic,  Hungary,  Israel,  Portugal,  Romania,  Slovakia,  Slovenia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of patients surviving without disease progression in each arm at 9 months
Secondary	PFS rates at 3,6,12 months
Secondary	Response rates
Secondary	Overall survival (OS) in each arm
Secondary	Safety