Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Capecitabine
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XELOX/Avastin<br>Capecitabine Oxaliplatin Bevacizumab | Drug: Oxaliplatin<br>* 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<br>* Other names: Eloxatin;Drug: Capecitabine<br>* 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<br>* Other names: Xeloda;Drug: Bevacizumab<br>* Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 2 - 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity profile |  | Toxicity assessment on each cycle | 
| Time to tumor progression |  | 1 year | 
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Colorectal cancer, Elderly, Chemotherapy, Capecitabine, Oxaliplatin, Bevacizumab