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

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ClinicalTrials.gov Identifier: NCT01024504
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : April 9, 2010
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Oxaliplatin Drug: Capecitabine Drug: Bevacizumab Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: XELOX/Avastin
Capecitabine Oxaliplatin Bevacizumab
 Drug: Oxaliplatin
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
Other Name: Eloxatin

Drug: Capecitabine
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
Other Name: Xeloda

Drug: Bevacizumab
Bevacizumab at the dose of 5 mg/Kgr (intravenous infusion) at day 1, every 2 weeks for a maximum of 12 consecutive cycles
Other Name: Avastin


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 2 - 4 months ]

Secondary Outcome Measures :
  1. Toxicity profile [ Time Frame: Toxicity assessment on each cycle ]
  2. Time to tumor progression [ Time Frame: 1 year ]
  3. Overall survival [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024504


Locations
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Greece
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
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
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Principal Investigator: John Souglakos, MD University Hospital of Crete, Dep of Medical Oncology
Principal Investigator: Lampros Vamvakas, MD University Hospital of Crete
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: John Souglakos, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT01024504     History of Changes
Other Study ID Numbers: CT/06.12
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2010
Keywords provided by Hellenic Oncology Research Group:
Cancer
Colorectal cancer
Elderly
Chemotherapy
 Capecitabine
Oxaliplatin
Bevacizumab
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
 Capecitabine
Oxaliplatin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action