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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the response proportion in patients with locally advanced, unresectable, or metastatic gastric cancer treated with capecitabine and oxaliplatin. Secondary 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.

Official Title
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A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaliplatin + Capecitabine<br>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<br> <br> Drug: oxaliplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate as Determined by RECIST. | 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. | Every 6 weeks through study completion for up to about 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | From the start of study treatment through study completion for up to about 18 weeks | 
| Progression-free Survival |  | Every 6 weeks through study completion for up to about 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer