Efficacy and Safety Study of a Modified XELOX Regimen in First-Line Treatment of Metastatic Colorectal Adenocarcinoma (mXELOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01552967
Recruitment Status : Unknown
Verified March 2012 by Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : March 13, 2012
Last Update Posted : March 28, 2012
Information provided by (Responsible Party):
Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary:
This is an open-label, phase II study to evaluate the efficacy and safety of a modified regimen of oxaliplatin and capecitabine on metastatic colorectal adenocarcinoma in the first-line therapy.

Condition or disease Intervention/treatment Phase
Colorectal Adenocarcinoma Drug: Capecitabine Phase 2

Detailed Description:

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating a Modified Regimen of Oxaliplatin and Capecitabine in First-Line Treatment of Metastatic Colorectal Adenocarcinoma
Study Start Date : March 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Capecitabine

    Oxaliplatin 85mg/m2 D1 and capecitabine 1g/m2 BID D1-D10, repeat every two weeks.

    Efficacy will be evaluated every three cycles.

Primary Outcome Measures :
  1. Overall response rate according to RECIST 1.1 [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: One year ]
  2. overall survival [ Time Frame: One Year ]
  3. Safety data of this regimen [ Time Frame: One Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent;
  • Patients with histologically or cytologically confirmed stage IV colorectal adenocarcinoma whose ECOG performance status are 0-2;
  • Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination;
  • At least 3 weeks since last major surgery;
  • At least 12 months since last adjuvant chemotherapy;
  • At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected;
  • Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields;
  • Patients with reproductive potential must use effective BC;
  • Required Screening Laboratory Criteria:

    • Hemoglobin 90g/L
    • WBC 3.5 x 109/L
    • Neutrophils 1.5 x 109/L
    • Platelets 100 x 109/L
    • Creatinine 133 umol/L and creatinine clearance 60 mL/min
  • A probable life expectancy of at least 6 months;

Exclusion Criteria:

  • Brain metastases;
  • Female of childbearing potential, pregnancy test is positive;
  • Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer;
  • Active infection;
  • Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk;
  • Sexually active patients refusing to practice adequate contraception;
  • Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator;
  • History of grade 3 or 4 toxicity to fluoropyrimidines;
  • Pre-existing neuropathy ≥ NCI CTC grade 2.

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 identifier (NCT number): NCT01552967

Contact: Yue Cai, Master 86-20-38250745

China, Guangdong
the Sixth Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Yue Cai, Master    86-20-38250745   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Principal Investigator: Jian Xiao Sixth Affiliated Hospital, Sun Yat-sen University

Responsible Party: Jian Xiao, Principal Investigator, Sixth Affiliated Hospital, Sun Yat-sen University Identifier: NCT01552967     History of Changes
Other Study ID Numbers: SAHMO-01
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Keywords provided by Jian Xiao, Sixth Affiliated Hospital, Sun Yat-sen University:
Colorectal cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents