Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT01024504
- Lead Sponsor
- Hellenic Oncology Research Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description XELOX/Avastin Bevacizumab Capecitabine Oxaliplatin Bevacizumab XELOX/Avastin Oxaliplatin Capecitabine Oxaliplatin Bevacizumab XELOX/Avastin Capecitabine Capecitabine Oxaliplatin Bevacizumab
- Primary Outcome Measures
Name Time Method Overall response rate 2 - 4 months
- Secondary Outcome Measures
Name Time Method Time to tumor progression 1 year Overall survival 1 year Toxicity profile Toxicity assessment on each cycle
Trial Locations
- Locations (6)
University General Hospital of Alexandroupolis, Dep of Medical Oncology
🇬🇷Alexandroupolis, Greece
Air Forces Military Hospital of Athens
🇬🇷Athens, Greece
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
State General Hospital of Larissa
🇬🇷Larissa, Greece
Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
🇬🇷Thessaloniki, Greece