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. Identifier: NCT00354224
Recruitment Status : Terminated (due to low accrual)
First Posted : July 20, 2006
Results First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Information provided by (Responsible Party):
Medical University of South Carolina

July 19, 2006
July 20, 2006
May 4, 2018
July 16, 2018
July 16, 2018
January 2005
August 2008   (Final data collection date for primary outcome measure)
Response Rate as Determined by RECIST. [ Time Frame: Every 6 weeks through study completion for up to about 18 weeks ]
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Not Provided
Complete list of historical versions of study NCT00354224 on Archive Site
  • Number of Adverse Events [ Time Frame: From the start of study treatment through study completion for up to about 18 weeks ]
  • Progression-free Survival [ Time Frame: Every 6 weeks through study completion for up to about 18 weeks ]
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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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: capecitabine
  • Drug: oxaliplatin
Experimental: Oxaliplatin + Capecitabine
Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day.
  • Drug: capecitabine
  • Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
August 2008
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 to 120 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000484638 ( Registry Identifier: PDQ (Physician Data Query) )
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Medical University of South Carolina
Medical University of South Carolina
Not Provided
Study Chair: Uzair B. Chaudhary, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center
Medical University of South Carolina
July 2018

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