Status:
COMPLETED
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-72 years
Phase:
PHASE3
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00469443
Start Date
December 1 2006
End Date
February 1 2010
Last Update
August 19 2010
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
401 Military Hospital of Athens
Athens, Greece