Randomisierte Studie zur Wirksamkeit von FOLFIRI in Kombination mit Cetuximab vs. Bevacizumab in der Erstlinien-Behandlung des metastasierten kolorektalen KarzinomsEnglish translation:Randomised study for efficiency of FOLFIRI in combination with Cetuximab vs. Bevacizumab in first-line-therapy of metastatic colorectal cancer - FIRE-3

Phase 1

• Conditions: Metastatic colorectal cancer; MedDRA version: 20.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000016864

• Registration Number: EUCTR2006-004030-32-DE
• Lead Sponsor: Klinikum der Ludwig-Maximilians Universität München, Klinikum Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-09
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

-Histologically confirmed adenocarcinoma of colon and rectum
-confirmation of a K-RAS wild type status ( in the primary tumor or in metastasis)
-stage IV
-general condition: 0-2 (ECOG/ WHO)
-suitable for application of chemotherapy
-written informed consent (first and second-line therapy)
-Age 18- 75
-clinical or ambulant treatment
-Life expectancy > 3 months
-minimum one measurable indicator leasion according to RECIST. Evaluation
of tumor manifestation 2 weeks or less before study entry.
-Male or female patients with reproductive potential must use an approved
contraceptive method
-Leucocytes = 3,0 x 10\9/L with Neutrophils = 1,5 x 10\9/L, Thrombocytes =
100 10\9/L, Hemoglobin = 5,6 mmol/L equivalent to 9 g/dL
-Serum bilirubin = 1,5x upper NL
-ALAT and ASAT = 2,5 x upper NL, in case of liver metastases ALAT and
ASAT = 5 x upper NL.
-Serum creatinine = 1,5 x upper NL
-An operation has to take place 4 weeks before study entry; a fine needle
biopsy must have been performed more than 1 week ago. Wounds must
have completely healed. The necessity of a big operation in the course of
the study is not to be expected. An exception is a resection of liver
metastases. If there should be he option of a secondary curative
operation Bevacizumab has to be discontinued 6 to 8 weeks before
operation.
-relevant toxicitys of therapies prior must have abate

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- confirmation of a K-RAS mutation
-previous exposure to EGFR-targeting therapy
-previous treatment with Bevacizumab
-prior chemotherapy of colorectal cancer, except adjuvant chemotherapy
wich was terminated at least 6 month before study entry
-experimental medical treatment within 30 days before study entry
-known hypersensitivity to elements of the study drug
-pregnant (exclusion diagnosis by beta-hCG-test) or breast-feeding
women
-clinically relevant coronary disease or myocardial infarction within 12
months before study entry or enhanced risk of uncontrolled arrhythmia
-acute or subacute intestinal obstruction or chronical-inflammatory enteritis
during anamnesis or chronical diarrhea
-symptomatic peritoneal carcinosis
-serious, non-healing wounds, ulcera or bone fracture
-uncontrolled hypertonia
-pronounced proteinuria
-arterial thromboembolism or haemorrhage within 6 months before study
entry (except tumor bleeding before tumorresection)
-hemorrhagic diathesis or thrombotic tendency
-therapeutic anticoagulation (marcumar-therapy, PTT-effective
heparinization)
-known DPD-insufficience (special screening not necessary)
-known glucuronisation defect (Gilbert´s disease) (special screening not
necessary)
-secondary malignancies during anamnesis within the last 5 years except
curatively treated basalioma or in situ carcinoma of the cervix
-known alcohol- or drug abuse
-clinical or psychological disorders that would prohibit to give a valid
informed consent or to perform the study
-a significant concomitant disorder which excludes the patient´s participation in from the
study in the opinion of the responsible physician
-absent or constricted legal capacity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparative validation of antitumor efficacy measured by objective remissionrate defined by RECIST-criteria (OR= CR+ PR), assessed within intent-to-treat-collective.;Secondary Objective: Determination of progression free survival<br>Determination of overall survival<br>Rate of liver resection with potentially curative approach<br>Evaluation of safety and compatibility (NCI-CTCAE-criteria)<br>Determination of time to failure of strategy<br>Determination of remission depth (maximum relative remission of tumor burden compared to baseline);Primary end point(s): Progression of metastatic colorectal cancer or patient's death