Metastatic Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Bevacizumab, XELIRI
Brief summary
This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.
Detailed description
The aim of this phase II study is to evaluate the efficacy of the combination XELIRI/AVASTIN in patients with mCRC, who have progressed in first line treatment with FOLFOX/AVASTIN. For AVASTIN was selected the dosing schedule of the trials TREE 1 and 2 \[17\], where Avastin was combined with capecitabine and oxaliplatin in a three weeks schedule and with adaptation of the dose in the 7,5 mg/kg
Interventions
DRUGCapecitabine
Capecitabine 2000 mg/m2 p.o. daily, for days 1-14, every 3 weeks for 6 cycles
DRUGBevacizumab
Bevacizumab 7.5 mg/kg intravenous (IV) on day 1 every 3 weeks for 6 cycles
DRUGIrinotecan
Irinotecan 250 mg/m2 IV on day 1 every 3 weeks for 6 cycles
Sponsors
University Hospital of Crete
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 according to the Response Evaluation Criteria in Solid Tumors * ECOG performance status ≤ 2 * Age 18 - 72 years * Patients who progress after 1st line therapy with FOLFOX/AVASTIN * Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit) renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function * Patients must be able to understand the nature of this study * Written informed consent
Exclusion criteria
* History of serious cardiac disease (unstable angina, congestive heart failure,uncontrolled cardiac arrhythmias) * History of myocardial infarction or stroke within 6 months * Clinically significant peripheral vascular disease * History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0 * Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 * Presence of central nervous system or brain metastasis * Evidence of bleeding diathesis or coagulopathy * Blood pressure \> 150/100 mmHg * Pregnant or lactating woman * Life expectancy \< 3 months * Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow * Metastatic infiltration of the liver \> 50% * Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy * Active infection requiring antibiotics on Day 1 * Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer * Psychiatric illness or social situation that would preclude study compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Time To Progression | 1 year |
| Toxicity profile | Toxicity assessment on each chemotherapy |
| Quality of life | Assessment every two cycles |
| Symptoms improvement | Assessment every two cycles |
| Overall Survival | 1 year |
Countries
Greece
Outcome results
None listed