Metastatic Colorectal Cancer
Conditions
Keywords
Cancer, Colorectal cancer, Elderly, Chemotherapy, Capecitabine, Oxaliplatin, Bevacizumab
Brief summary
This trial will evaluate the efficacy and safety of the capecitabine and oxaliplatine plus bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer.
Detailed description
Capecitabine, oxaliplatin and bevacizumab are well known active agents in the treatment of mCRC. The treatment of elderly patients with mCRC is an area of investigation. The role of comprehensive geriatric assessment in treatment efficacy and tolerance is an area of investigation.
Interventions
DRUGOxaliplatin
Oxaliplatin at the dose of 85 mg/m2 over a 4 hour intravenous infusion at day 1 every 2 weeks for a maximum of 12 consecutive cycles
DRUGCapecitabine
Capecitabine at the dose of 1500 mg/m2 per os at days 1 to 7 every 2 weeks for a maximum of 12 consecutive cycles
DRUGBevacizumab
Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles
Sponsors
University Hospital of Crete
Hellenic Oncology Research Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the colon or rectum * Stage IV * Existence of two-dimensional measurable disease. The measurable disease should not have been irradiated. * Absence or irradiated and stable central nervous system metastatic disease. * Life expectancy of more than 3 months. * Age ≥ 70 years. * Performance status (WHO) ≤ 2. * Adequate bone marrow function (Absolute neutrophil count \>1000/mm3, Platelet count \>100000/mm3, Hemoglobin \>9gr/mm3). * Adequate liver (Bilirubin \<1.5 times upper limit of normal and SGOT/SGPT \<2 times upper limit of normal). * Creatinine clearance (Cockcroft-Gault formula) \>30ml/min. * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer. * Presence of a reliable care giver. * Informed consent.
Exclusion criteria
* Prior chemotherapy for metastatic disease. * History of thromboembolic disease or myocardial infraction within the last 6 months. * Peripheral neuropathy ≥ grade 2. * Bowel obstruction or chronic diarrhea. * Psychiatric illness or social situation that would preclude study compliance. * Other concurrent uncontrolled illness. * Other concurrent investigational agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | 2 - 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity profile | Toxicity assessment on each cycle |
| Time to tumor progression | 1 year |
| Overall survival | 1 year |
Countries
Greece
Outcome results
None listed