S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed gallbladder cancer or cholangiocarcinoma
• * Locally advanced or metastatic disease that is unresectable
• * Eligible subtypes:
• * Adenocarcinoma, intestinal type
• * Adenocarcinoma, not otherwise specified (NOS)
• * Papillary carcinoma
• * Clear cell adenocarcinoma
• * Mucinous carcinoma
• * Signet ring cell carcinoma
• * Squamous cell carcinoma
• * Adenosquamous carcinoma
• * Small cell carcinoma
• * Undifferentiated carcinoma
• * Carcinoma, NOS
• OR
• Histologically confirmed adenocarcinoma of a metastatic site with clinical documentation\* of gallbladder or bile duct involvement and no evidence of another primary
• NOTE: \*If clinical documentation of gallbladder or bile duct involvement is not possible due to removal of the organ, a clinically and/or radiographically consistent picture plus pathologic findings from the metastatic site consistent with cholangiocarcinoma are allowed
• Measurable disease located outside prior radiotherapy port
• No carcinoid tumors or sarcomas
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• Zubrod 0-2
• Life expectancy:
• Not specified
• Hematopoietic:
• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin no greater than 3 times upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) no greater than 2.5 times ULN (5 times ULN if liver metastasis is present)
• Renal:
• Creatinine clearance at least 30 mL/min
• Cardiovascular:
• No clinically significant cardiac disease that is not well controlled by medication
• No congestive heart failure
• No symptomatic coronary artery disease
• No cardiac arrhythmias
• No myocardial infarction within the past 12 months
• Gastrointestinal:
• Able to swallow and/or receive medications via gastrostomy feeding tube
• No intractable nausea or vomiting
• No malabsorption syndrome
• Other:
• No severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluorouracil
• No other malignancy within the past 5 years except:
• * Adequately treated basal cell or squamous cell skin cancer
• * Carcinoma in situ of the cervix
• * Adequately treated stage I or II cancer currently in complete remission
• Not pregnant or nursing
• Fertile patients must use effective contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Prior neoadjuvant or adjuvant immunotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
• No concurrent immunotherapy
• Chemotherapy:
• Prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
• No other concurrent chemotherapy
• Endocrine therapy:
• Prior neoadjuvant or adjuvant hormonal therapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
• No concurrent hormonal therapy
• Radiotherapy:
• See Disease Characteristics
• See Chemotherapy
• Recovered from prior radiotherapy
• Prior neoadjuvant or adjuvant radiotherapy allowed provided therapy was completed at least 1 year before documented recurrence or metastatic disease
• No prior radiotherapy to 25% or more of bone marrow
• No concurrent radiotherapy except for palliation of metastatic sites not considered target lesions
• Surgery:
• At least 2 weeks since prior surgery for this malignancy and recovered
• Other:
• No prior treatment for metastatic disease
• No other concurrent therapy for this cancer