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Trial record 54 of 439 for:    colon cancer AND Capecitabine AND colon cancer

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

Tracking Information
First Submitted Date  ICMJE November 26, 2009
First Posted Date  ICMJE December 2, 2009
Last Update Posted Date April 9, 2010
Study Start Date  ICMJE March 2006
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
Overall response rate [ Time Frame: 2 - 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01024504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2009)
  • Toxicity profile [ Time Frame: Toxicity assessment on each cycle ]
  • Time to tumor progression [ Time Frame: 1 year ]
  • Overall survival [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Capecitabine Plus Oxaliplatin Plus Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Multicenter Phase II Study of the Capecitabine, Oxaliplatin and Bevacizumab as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: XELOX/Avastin
Capecitabine Oxaliplatin Bevacizumab
Interventions:
  • Drug: Oxaliplatin
  • Drug: Capecitabine
  • Drug: Bevacizumab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 1, 2009)
46
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01024504
Other Study ID Numbers  ICMJE CT/06.12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Souglakos, University Hospital of Crete
Study Sponsor  ICMJE Hellenic Oncology Research Group
Collaborators  ICMJE University Hospital of Crete
Investigators  ICMJE
Principal Investigator: John Souglakos, MD University Hospital of Crete, Dep of Medical Oncology
Principal Investigator: Lampros Vamvakas, MD University Hospital of Crete
PRS Account Hellenic Oncology Research Group
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP