oxaliplatin and capecitabine in treating patients with advanced esophageal cancer or stomach cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: 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

Keywords: stage iv gastric cancer recurrent gastric cancer stage iii esophageal cancer stage iv esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus