Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00469443
- Lead Sponsor
- Hellenic Oncology Research Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 5-Fluorouracil FOLFIRI/Avastin 1 Irinotecan FOLFIRI/Avastin 1 Leucovorin FOLFIRI/Avastin 1 Bevacizumab FOLFIRI/Avastin 2 Bevacizumab XELIRI/Avastin 2 Capecitabine XELIRI/Avastin 2 Irinotecan XELIRI/Avastin
- Primary Outcome Measures
Name Time Method Time To Progression 1 year
- Secondary Outcome Measures
Name Time Method Symptoms improvement Assessment every two cycles Quality of life Assessment every two cycles Objective Response Rate Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) Overall Survival Probability of 1-year survival (%) Toxicity profile Toxicity assessment on each chemotherapy cycle
Trial Locations
- Locations (8)
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
🇬🇷Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
🇬🇷Athens, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
🇬🇷Alexandroupolis, Greece
401 Military Hospital of Athens
🇬🇷Athens, Greece
Air Forces Military Hospital of Athens
🇬🇷Athens, Greece
State General Hospital of Larissa
🇬🇷Larissa, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
🇬🇷Thessaloniki, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
🇬🇷Piraeus, Greece