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Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer

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.
ClinicalTrials.gov Identifier: NCT00354224
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : January 26, 2009
Information provided by:
National Cancer Institute (NCI)

July 19, 2006
July 20, 2006
January 26, 2009
January 2005
August 2008   (Final data collection date for primary outcome measure)
Response rate
Not Provided
Complete list of historical versions of study NCT00354224 on ClinicalTrials.gov Archive Site
  • Tolerance
  • Toxicity
  • Median and progression-free survival
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Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer
A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.



  • Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin.


  • Determine the tolerability and toxicity of this regimen in these patients.
  • Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: capecitabine
  • Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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August 2008   (Final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed gastric cancer

    • Locally advanced, unresectable, or metastatic disease
  • Measurable disease, defined as at least 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
  • No known brain metastases


  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • AST/ALT ≤ 2.5 times upper limit of normal
  • Creatinine ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study and for 6 months after completion of study treatment
  • Able to swallow
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to fluoropyrimidines or platinum chemotherapy agents
  • No uncontrolled intercurrent illness including, but not limited to the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situations that would preclude study compliance


  • More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 6 months since prior radiotherapy with capecitabine as a radioenhancer
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent chemotherapy
  • No concurrent palliative radiotherapy
  • No concurrent hormonal therapy except for the following:

    • Steroids for adrenal failure
    • Hormones for nondisease related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical University of South Carolina
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Study Chair: Uzair B. Chaudhary, MD Medical University of South Carolina
National Cancer Institute (NCI)
January 2008

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