Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.

OBJECTIVES:

Primary

* Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine.

Secondary

* Determine the time to progression and overall survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Assess the quality of life of patients treated with this regimen.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR.

Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy).

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists

  * Unresectable disease
  * Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach
* Measurable disease
* No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 3 times ULN
* Alkaline phosphatase no greater than 2 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Other:

* Able to swallow capecitabine
* No unresolved gastrointestinal bleeding
* No uncontrolled infection
* No chronic debilitating disease
* No peripheral neuropathy grade 2 or greater
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior immunotherapy or biological therapy for recurrent or metastatic disease
* No concurrent biologic agents

Chemotherapy:

* No prior chemotherapy for recurrent or metastatic disease
* Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed
* No other concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Chemotherapy
* No prior radiotherapy for recurrent or metastatic disease
* No prior radiotherapy to more than 25% of the bone marrow
* Prior adjuvant or neoadjuvant radiotherapy allowed
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* More than 4 weeks since prior abdominal exploration with surgical resection
* More than 3 weeks since prior abdominal exploration without surgical resection

Other:

* No concurrent oral cryotherapy during oxaliplatin administration