A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
70 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Outcome Time Frame:
2 - 4 months
Safety Issue:
No
Principal Investigator
John Souglakos, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital of Crete, Dep of Medical Oncology
Authority:
Greece: National Organization of Medicines
Study ID:
CT/06.12
NCT ID:
NCT01024504
Start Date:
March 2006
Completion Date:
March 2010
Related Keywords:
- Metastatic Colorectal Cancer
- Cancer
- Colorectal cancer
- Elderly
- Chemotherapy
- Capecitabine
- Oxaliplatin
- Bevacizumab
- Colorectal Neoplasms
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