Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00469443
First received: May 3, 2007
Last updated: August 18, 2010
Last verified: August 2010

May 3, 2007
August 18, 2010
December 2006
February 2010   (final data collection date for primary outcome measure)
Time To Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Time To Progression
Complete list of historical versions of study NCT00469443 on ClinicalTrials.gov Archive Site
  • Objective Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Probability of 1-year survival (%) ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
  • Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]
Objective Response Rate; Overall Survival; Toxicity profile; Quality of life; Symptoms improvement
Not Provided
Not Provided
 
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
A Randomized Phase III Study of Irinotecan Plus 5-fluorouracil Plus Leucovorin and Bevacizumab (FOLFIRI+Avastin) Versus Irinotecan Plus Capecitabine and Bevacizumab (XELIRI+Avastin) as 1st Line Treatment of Locally Advanced or Metastatic Colorectal Cancer

This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.

There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: Irinotecan
    Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
    Other Name: CPT-11
  • Drug: 5-Fluorouracil
    5-Fluorouracil 400 mg/m2 infused over 10 min IV and 5-FU 600 mg/m2 infused over 22 hours IV, on Day 1 and 2 (De Grammont regimen), every 2 weeks for 10 cycles
    Other Name: 5-FU
  • Drug: Leucovorin
    Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
    Other Name: LV
  • Drug: Capecitabine
    Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
    Other Name: Xeloda
  • Drug: Bevacizumab
    Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
    Other Name: Avastin
  • Drug: Bevacizumab
    Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
    Other Name: Avastin
  • Drug: Irinotecan
    Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
    Other Name: CPT-11
  • Experimental: 1
    FOLFIRI/Avastin
    Interventions:
    • Drug: Irinotecan
    • Drug: 5-Fluorouracil
    • Drug: Leucovorin
    • Drug: Bevacizumab
  • Experimental: 2
    XELIRI/Avastin
    Interventions:
    • Drug: Capecitabine
    • Drug: Bevacizumab
    • Drug: Irinotecan
Souglakos J, Ziras N, Kakolyris S, Boukovinas I, Kentepozidis N, Makrantonakis P, Xynogalos S, Christophyllakis Ch, Kouroussis Ch, Vamvakas L, Georgoulias V, Polyzos A. Randomised phase-II trial of CAPIRI (capecitabine, irinotecan) plus bevacizumab vs FOLFIRI (folinic acid, 5-fluorouracil, irinotecan) plus bevacizumab as first-line treatment of patients with unresectable/metastatic colorectal cancer (mCRC). Br J Cancer. 2012 Jan 31;106(3):453-9. doi: 10.1038/bjc.2011.594. Epub 2012 Jan 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
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
  • ECOG performance status ≤ 2
  • Age 18 - 72 years
  • 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 with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of Avastin
  • Patients must be able to understand the nature of this study
  • Written informed consent

Exclusion Criteria:

  • Previous 1st line chemotherapy
  • Adjuvant chemotherapy with Irinotecan regimen with relapse < 6 months after the completion
  • Active infection
  • History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • Previous radiotherapy within the last 4 weeks or > 25% of bone marrow
  • Patients with unstable CNS metastases
  • Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
  • Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women
  • Patients > 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
Both
18 Years to 72 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00469443
CT/05.16
No
J.Sougklakos, Hellenic Oncology Research Group
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: John Souglakos, MD johnsougl@gmail.com
Hellenic Oncology Research Group
August 2010

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