Colorectal Cancer
Conditions
Keywords
Metastatic colorectal cancer, Irinotecan, Capecitabine, Bevacizumab
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.
Interventions
DRUGIrinotecan
Irinotecan 150mg/m2 IV on day 1 every 2 weeks for 10 cycles
DRUG5-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
DRUGLeucovorin
Leucovorin 200 mg/m2 infused over 2 hours IV, on day 1 and 2 every 2 weeks for 10 cycles
DRUGCapecitabine
Capecitabine 2000mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
DRUGBevacizumab
Bevacizumab 5mg/kg IV on day 1 every 2 weeks for 10 cycles
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time To Progression | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Quality of life | Assessment every two cycles |
| Symptoms improvement | Assessment every two cycles |
Countries
Greece
Outcome results
None listed