Clinical trial NCT00286130: Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: metastatic colorectal cancer
FOLFOX 6
FOLFIRI
Lead sponsor: Central European Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: the percentage of patients surviving without disease progression in each arm at 9 months
Secondary outcomes:
measure: PFS rates at 3,6,12 months
measure: Response rates
measure: Overall survival (OS) in each arm
measure: Safety
Other outcomes:
Locations:
city: Leoben
country: Austria
facility: LKH Leoben, Abt. für Innere Medizin
state: Steiermark
city: Wien
country: Austria
facility: Univ. Klinik für Innere Medizin I
city: Sarajevo
country: Bosnia and Herzegovina
facility: Institute of Oncology
city: Sofia
country: Bulgaria
facility: University Hospital "Queen Joanna"
city: Sofia
country: Bulgaria
facility: SBALO National Oncology Center
city: Zagreb
country: Croatia
facility: University Hospital for Tumors
city: Zagreb
country: Croatia
facility: University Hospital Rebro
city: Nikosia
country: Cyprus
facility: Bank of Cyprus Oncology Center
city: Brno
country: Czech Republic
facility: Univ. Hospital Brno, Dept. Of Clinical Oncology
city: Prague
country: Czech Republic
facility: Charles University Prague, Dep. of Oncology
city: Budapest
country: Hungary
facility: National Medical Center
city: Szomathely
country: Hungary
facility: Markusovsy Hospital
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc County Hospital
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Souraski Medical Center
city: Amadora
country: Portugal
facility: Hospital Amadora Sintra, Servico de Oncologia
city: Beja
country: Portugal
facility: Hospital de Beja
city: Faro
country: Portugal
facility: Hospital Distrital de Faro
city: Porto
country: Portugal
facility: Hospital Geral de Sto. António
city: Viseu
country: Portugal
facility: Hospital San Teotóno -
city: Bucuresti
country: Romania
facility: Institutul Oncologic Bucuresti
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Cluj
city: Bratislava
country: Slovakia
facility: National Cancer Institute
city: Ljubljana
country: Slovenia
facility: Institute of Oncology
city: Ankara
country: Turkey
facility: Ankara Hacettepe University, Oncology Unit
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Izmir
country: Turkey
facility: 9 Eyul University Medical Faculty, Dep of Oncology
Study officials:
affiliation: Dep. of Internal Medicine I, Medical University of Vienna
name: Werner Scheithauer, MD
role: PRINCIPAL_INVESTIGATOR
References: