Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction

• Deemed unresectable and not a candidate for potentially curative treatment (e.g., surgical resection or combined modality therapy)

  • At least 4 weeks since prior abdominal exploration with resection (3 weeks without resection)
  • No other more conventional forms of therapy available with a reasonable chance of cure or significant palliation

• Measurable disease*

  • The following are not considered measurable disease:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Abdominal masses that are not confirmed and followed by imaging
    • Cystic lesions NOTE: *Patients having only lesions measuring ≥ 1 cm to < 2 cm must use spiral CT scan for all tumor assessments.
• No untreated or treated but symptomatic 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 2.5 times ULN if alkaline phosphatase is less than ULN OR
• Alkaline phosphatase no greater than 4 times ULN if AST less than ULN

Renal

• Creatinine normal
• Creatinine clearance at least 60 mL/min

Cardiovascular

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

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Ability to swallow capecitabine
• No prior anaphylactic reaction to any taxane
• No prior severe reaction to fluoropyrimidine
• No prior poor tolerance to capecitabine
• No known sensitivity or poor tolerance to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No uncontrolled infection
• No uncontrolled seizure disorder
• No chronic debilitating disease
• No peripheral neuropathy of any etiology greater than grade 1
• No diabetes mellitus
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma or adequately treated noninvasive carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy or biologic therapy for recurrent or metastatic disease
• No concurrent biologic therapy

Chemotherapy

• No prior chemotherapy for recurrent or metastatic disease except for the following:

  • Adjuvant chemotherapy after complete resection of the original tumor
  • Neoadjuvant chemotherapy followed by surgical resection of the original tumor
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy except for the following:

  • Adjuvant radiotherapy after complete resection of the original tumor
  • Neoadjuvant radiotherapy followed by surgical resection of the original tumor
• No prior radiotherapy to 25% or more of the bone marrow
• More than 4 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• No prior organ allograft

Other

• No concurrent brivudine or sorivudine