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

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ClinicalTrials.gov Identifier: NCT00433927
Recruitment Status : Unknown
Verified March 2014 by PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
First Posted : February 12, 2007
Last Update Posted : March 14, 2014
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Colorectal Cancer Drug: 5-FU Drug: folinic acid Drug: irinotecan Drug: cetuximab Drug: bevacizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Trial Evaluating FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab in First Line Treatment of Metastatic Colorectal Cancer.
Study Start Date : January 2007
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A
FOLFIRI plus Cetuximab
 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
Active Comparator: Arm B
FOLFIRI plus Bevacizumab
 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: bevacizumab
Bevacizumab 5 mg/kg iv over 30 to 90 minutes d 1


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: approximate 6 months after randomisation ]

Secondary Outcome Measures :
  1. Median progression free survival [ Time Frame: approximate 6 months after randomisation ]
  2. Median overall survival [ Time Frame: approximate 3 years after randomisation ]
  3. Secondary resection rate with curative intent [ Time Frame: up to 3 months after end of treatment ]
  4. Safety and toxicity (according to NCI-CTCAE) [ Time Frame: approximate 6 months after randomisation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433927


Locations
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Germany
University of Munich - Klinikum Grosshadern
Munich, Germany, 81377
Sponsors and Collaborators
PD Dr. med. Volker Heinemann
Merck KGaA, Darmstadt, Germany
Investigators
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Principal Investigator: Volker Heinemann, MD University of Munich - Klinikum Grosshadern
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PD Dr. med. Volker Heinemann, Sponsor Delegated Person, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00433927    
Other Study ID Numbers: FIRE-3
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: March 2014
Keywords provided by PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich:
metastatic
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Leucovorin
 Folic Acid
Bevacizumab
Cetuximab
Irinotecan
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors