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

Primary Purpose

Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Oxaliplatin
Capecitabine
Bevacizumab
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Cancer, Colorectal cancer, Elderly, Chemotherapy, Capecitabine, Oxaliplatin, Bevacizumab

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology
  • Air Forces Military Hospital of Athens
  • IASO General Hospital of Athens, 1st Dep of Medical Oncology
  • Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • State General Hospital of Larissa
  • Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XELOX/Avastin

Arm Description

Capecitabine Oxaliplatin Bevacizumab

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Toxicity profile
Time to tumor progression
Overall survival

Full Information

First Posted
November 26, 2009
Last Updated
April 8, 2010
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT01024504
Brief Title
Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
Official Title
A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Cancer, Colorectal cancer, Elderly, Chemotherapy, Capecitabine, Oxaliplatin, Bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XELOX/Avastin
Arm Type
Experimental
Arm Description
Capecitabine Oxaliplatin Bevacizumab
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
2 - 4 months
Secondary Outcome Measure Information:
Title
Toxicity profile
Time Frame
Toxicity assessment on each cycle
Title
Time to tumor progression
Time Frame
1 year
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Souglakos, MD
Organizational Affiliation
University Hospital of Crete, Dep of Medical Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lampros Vamvakas, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
IASO General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa
City
Larissa
Country
Greece
Facility Name
Theagenion Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
24755296
Citation
Vamvakas L, Matikas A, Karampeazis A, Hatzidaki D, Kakolyris S, Christophylakis C, Boukovinas I, Polyzos A, Georgoulias V, Souglakos J. Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG). BMC Cancer. 2014 Apr 22;14:277. doi: 10.1186/1471-2407-14-277.
Results Reference
derived

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

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