A Phase I Trial of Epirubicin, Carboplatin and Capecitabine in Adult Cancer Patients

Inclusion Criteria

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