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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2009-11-26
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-08
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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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.

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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