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

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.

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