Capecitabine, Epirubicin, and Carboplatin in Treating Patients With Progressive, Unresectable, or Metastatic Cancer

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring unspecified adult solid tumor, protocol specific, recurrent gastric cancer, stage IV gastric cancer, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer, recurrent gallbladder cancer, unresectable gallbladder cancer Read More

DISEASE CHARACTERISTICS:

• Pathologically confirmed cancer, meeting 1 of the following criteria:

  • Disease that has progressed on standard therapy
  • Locally advanced but unresectable primary or recurrent solid tumor
  • Metastatic disease, including previously untreated metastatic disease for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancer for which no effective standard therapy exists)
• No other potentially curative treatment options available (e.g., surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy)
• No leukemia or lymphoma
• No primary CNS malignancies or CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.6 mg/dL
• Left ventricular ejection fraction ≥ 50%
• No other medical illness that would preclude study treatment
• No active infection requiring IV antibiotic therapy unless the infection has resolved
• No history of allergy to platinum compounds, mannitol, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy
• No history of unexpectedly severe intolerance to fluorouracil
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior therapy
• No prior doxorubicin at cumulative doses > 300 mg/m²
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) or immunotherapy
• At least 2 weeks since prior radiotherapy
• At least 8 weeks since prior strontium therapy
• At least 4 weeks since prior and no concurrent sorivudine or brivudine
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent cimetidine