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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Irinotecan
5-Fluorouracil
Leucovorin
Capecitabine
Bevacizumab
Bevacizumab
Irinotecan
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic colorectal cancer, Irinotecan, Capecitabine, Bevacizumab

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology
  • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • 401 Military Hospital of Athens
  • Air Forces Military Hospital of Athens
  • State General Hospital of Larissa
  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

FOLFIRI/Avastin

XELIRI/Avastin

Outcomes

Primary Outcome Measures

Time To Progression

Secondary Outcome Measures

Objective Response Rate
Overall Survival
Toxicity profile
Quality of life
Symptoms improvement

Full Information

First Posted
May 3, 2007
Last Updated
August 18, 2010
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT00469443
Brief Title
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Metastatic colorectal cancer, Irinotecan, Capecitabine, Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
FOLFIRI/Avastin
Arm Title
2
Arm Type
Experimental
Arm Description
XELIRI/Avastin
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11
Intervention Description
Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
LV
Intervention Description
Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab 7,5mg/kg IV on day 1 every 3 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11
Intervention Description
Irinotecan 250mg/m2 IV on day 1 every 3 weeks for 6 cycles
Primary Outcome Measure Information:
Title
Time To Progression
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Title
Overall Survival
Time Frame
Probability of 1-year survival (%)
Title
Toxicity profile
Time Frame
Toxicity assessment on each chemotherapy cycle
Title
Quality of life
Time Frame
Assessment every two cycles
Title
Symptoms improvement
Time Frame
Assessment every two cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Souglakos, MD
Organizational Affiliation
johnsougl@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa
City
Larissa
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
22240792
Citation
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.
Results Reference
derived

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

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