Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach 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.

Detailed description: 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: 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

Relevance to patient case: not relevant