Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

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. Identifier: NCT00681876
Recruitment Status : Terminated (Due to poor accrual)
First Posted : May 21, 2008
Last Update Posted : February 13, 2013
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group

May 19, 2008
May 21, 2008
February 13, 2013
April 2008
February 2010   (Final data collection date for primary outcome measure)
Time To Progression [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00681876 on Archive Site
  • Objective Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ]
  • Quality of life, Symptoms improvement [ Time Frame: Assessment every two cycles ]
Same as current
Not Provided
Not Provided
Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer
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
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.
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
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Irinotecan
    Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
    Other Names:
    • CPT-11
    • Campto
  • Drug: Avastin
    Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
    Other Name: Bevacizumab
  • Drug: Erbitux
    Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression
    Other Name: Cetuximab
Experimental: 1
  • Drug: Irinotecan
  • Drug: Avastin
  • Drug: Erbitux
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2010
February 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 72 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hellenic Oncology Research Group
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: John Souglakos, MD University Hospital of Crete
Hellenic Oncology Research Group
February 2013

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