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Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer.

Phase 3
18 Years
75 Years
Open (Enrolling)
Neoplasm Metastasis, Colorectal Cancer

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Trial Information

Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer.

Inclusion Criteria:

- KRAS-Wildtype status

- Histologically confirmed adenocarcinoma of the colon or rectum.

- Stage IV disease.

- ECOG 0-2.

- Patients considered suitable for application of chemotherapy.

- Age 18 - 75 years.

- In- or outpatient treatment.

- Estimated life expectancy > 3 months.

- Measurable index lesion according to RECIST criteria. Evaluation of tumor
manifestations ≤ 2 weeks prior to treatment start.

- Effective contraception.

- Adequate hematologic function: leukocytes >= 3000/µl, neutrophils >= 1500/µl,
platelets >= 100.000/µ, and hemoglobin >= 9g/dl.

- Bilirubin <= 1,5x upper limit of normal (ULN).

- ALAT and ASAT <= 2,5x ULN, in case of liver metastases <= 5x ULN.

- Serum creatinine <= 1,5x ULN.

- No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1
week prior to treatment start. Operation sequels need to be completely healed. Major
operations must not be expected at time of study begin, except for potential
secondary resection of liver metastases. In case of secondary resection of liver
metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.

- No relevant toxicities due to prior medical treatment at time of study entry.

Exclusion Criteria:

- KRAS-Mutation of the tumor

- Prior treatment directed against the epidermal growth factor receptor (EGFR).

- Prior treatment with bevacizumab.

- Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating
back > 6 months prior to study entry.

- Experimental medical treatment within 30 days prior to study entry.

- Known hypersensitivity reaction to any study medication.

- Pregnant or breast feeding women (pregnancy needs to be excluded by testing of

- Known or suspected cerebral metastases.

- Clinically significant coronary heart disease, myocardial infarction within the last
12 months or high risk of uncontrolled arrhythmia.

- Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.

- Symptomatic peritoneal carcinosis.

- Severe chronic wounds, ulcera or bone fracture.

- Uncontrolled hypertension.

- Severe proteinuria (nephrotic syndrome).

- Arterial thromboembolic events or hemorrhage within 6 months prior to study entry
(except tumor bleeding surgically treated by tumor resection).

- Bleeding diatheses or coagulopathy.

- Full dose anticoagulation.

- Known DPD-deficiency (special screening not required).

- Known glucuronidation-deficiency (special screening not required).

- Medical history of other malignant disease within 5 years prior to study entry,
except for basalioma, and in-situ cervical carcinoma if treated with curative intent.

- Known alcohol or drug abuse.

- Medical or psychiatric condition which contradicts participation of study.

- Limited legal capacity.

Type of Study:


Study Design:

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

Outcome Measure:

Objective response rate

Outcome Time Frame:

approximate 6 months after randomisation

Safety Issue:


Principal Investigator

Volker Heinemann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Munich - Klinikum Grosshadern


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2007

Completion Date:

December 2016

Related Keywords:

  • Neoplasm Metastasis
  • Colorectal Cancer
  • metastatic
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis