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Completed

NCT Number: NCT01024504

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

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin

Drug

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 names: Eloxatin

Capecitabine

Drug

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 names: Xeloda

Bevacizumab

Drug

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

Other names: Avastin

Primary outcomes

  1. Overall response rate

    Time frame: 2 - 4 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Collaborators

  • University Hospital of Crete

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Apr 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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