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Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer
This study is currently recruiting participants.
Verified by Hellenic Oncology Research Group, July 2008
Sponsors and Collaborators: Hellenic Oncology Research Group
University Hospital of Crete
Information provided by: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00681876
  Purpose

This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.


Condition Intervention Phase
Colorectal Cancer
Drug: Irinotecan
Drug: Avastin
Drug: Erbitux
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride Bevacizumab Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title: Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Time To Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Quality of life, Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Irinotecan+Avastin+Erbitux
Drug: Irinotecan
Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
Drug: Avastin
Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
Drug: Erbitux
Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression

Detailed Description:

Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed locally advanced or metastatic colorectal cancer.
  • Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  • ECOG performance status ≤ 2
  • Age 18 - 72 years
  • Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin)
  • Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL),renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
  • Patients must be able to understand the nature of this study
  • Written informed consent

Exclusion Criteria:

  • History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias).
  • History of myocardial infarction or stroke within 6 months.
  • Clinically significant peripheral vascular disease.
  • History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
  • Presence of central nervous system or brain mets.
  • Evidence of bleeding diathesis or coagulopathy.
  • Patients with known hypersensitive reaction to cetuximab
  • Blood pressure > 150/100 mmHg.
  • Pregnant or lactating woman.
  • Life expectancy < 3 months.
  • Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
  • Metastatic infiltration of the liver >50%.
  • Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy.
  • Active infection requiring antibiotics on Day 1.
  • Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
  • Psychiatric illness or social situation that would preclude study compliance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681876

Contacts
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr

Locations
Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD     +302106442666     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Stelios Giassas, MD            
University General Hospital of Alexandroupolis, Dep of Medical Oncology Recruiting
Alexandroupolis, Greece
Contact: Dora Hatzidaki     +302810392570     dorachat@med.uoc.gr    
Contact: Eva Maragkoudaki     +302810392857     dorachat@med.uoc.gr    
Principal Investigator: Stelios Kakolyris, MD            
State General Hospital of Larissa Recruiting
Larissa, Greece
Contact: Nikoleta Karkatzou, MD     +302106448666     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Athanasios Athanasiadis, MD            
Air Forces Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD     +302106448666     secretary@horg.gr    
Contact: Spyros Georgiadis, MD     +302106457968     secretary@horg.gr    
Principal Investigator: Nikos Kentepozidis, MD            
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD     +302106448666     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Ioannis Boukovinas, MD            
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Recruiting
Piraeus, Greece
Contact: Nikoleta Karkatzou, MD     +302106448666     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Nikos Ziras, MD            
: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD     +302106448666     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Aris Polyzos, MD            
401 Military Hospital of Athens Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD     +302106448666     secretary@horg.gr    
Contact: Spyros Georgiadis     +302106457968     secretary@horg.gr    
Principal Investigator: Charalampos Christophillakis, MD            
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: John Souglakos, MD University Hospital of Crete
  More Information

Responsible Party: Hellenic Oncology Research Group ( J.Sougklakos )
Study ID Numbers: CT/05.32
Study First Received: May 19, 2008
Last Updated: July 16, 2008
ClinicalTrials.gov Identifier: NCT00681876  
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Metastatic colorectal cancer
Second line
Irinotecan
Erbitux (Cetuximab)
Avastin (Bevacizumab)

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Cetuximab
Disease Progression
Bevacizumab
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 14, 2009