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5-FU, Folinic Acid and Irinotecan (FOLFIRI) Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer (CRC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433927
First Posted: February 12, 2007
Last Update Posted: March 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
February 9, 2007
February 12, 2007
March 14, 2014
January 2007
April 2014   (Final data collection date for primary outcome measure)
Objective response rate [ Time Frame: approximate 6 months after randomisation ]
Objective response rate
Complete list of historical versions of study NCT00433927 on ClinicalTrials.gov Archive Site
  • Median progression free survival [ Time Frame: approximate 6 months after randomisation ]
  • Median overall survival [ Time Frame: approximate 3 years after randomisation ]
  • Secondary resection rate with curative intent [ Time Frame: up to 3 months after end of treatment ]
  • Safety and toxicity (according to NCI-CTCAE) [ Time Frame: approximate 6 months after randomisation ]
  • Median progression free survival
  • Median overall survival
  • Secondary resection rate with curative intent
  • Safety and toxicity (according to NCI-CTCAE)
Not Provided
Not Provided
 
5-FU, Folinic Acid and Irinotecan (FOLFIRI) Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment Colorectal Cancer (CRC)
Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer.
The FIRE-3 trial is a multicenter randomized phase III trial investigating 5-FU, folinic acid and irinotecan (FOLFIRI) plus cetuximab versus FOLFIRI plus bevacizumab in first line treatment of metastatic colorectal cancer. Planned accrual is 284 evaluable patients per treatment arm. The primary study endpoint is objective response rate. Secondary endpoints are median progression free survival, median overall survival, safety, and secondary resection rate.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Neoplasm Metastasis
  • Colorectal Cancer
  • Drug: 5-FU
    5-FU 400 mg/m² Bolus day 1 5-FU 2400 mg/m² iv over 46 h day 1-2
  • Drug: folinic acid
    Folinsäure (racemisch) 400 mg/m² iv, 120 min d 1
  • Drug: irinotecan
    Irinotecan 180 mg/m² iv, 30 - 90 min day 1
  • Drug: cetuximab
    Cetuximab initial 400mg/m² as 120 min infusion, than 250 mg/m² iv as 60 min infusion d 1 + 8
  • Drug: bevacizumab
    Bevacizumab 5 mg/kg iv over 30 to 90 minutes d 1
  • Active Comparator: Arm A
    FOLFIRI plus Cetuximab
    Interventions:
    • Drug: 5-FU
    • Drug: folinic acid
    • Drug: irinotecan
    • Drug: cetuximab
  • Active Comparator: Arm B
    FOLFIRI plus Bevacizumab
    Interventions:
    • Drug: 5-FU
    • Drug: folinic acid
    • Drug: irinotecan
    • Drug: bevacizumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
568
December 2016
April 2014   (Final data collection date for primary outcome measure)

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 beta-HCG).
  • 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00433927
FIRE-3
Not Provided
Not Provided
Not Provided
PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
PD Dr. med. Volker Heinemann
Merck KGaA
Principal Investigator: Volker Heinemann, MD University of Munich - Klinikum Grosshadern
Ludwig-Maximilians - University of Munich
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP