Phase I Study Of Oral Etoposide In Combination With ORZEL (UFT + Leucovorin) For Advanced Non-Hematological Malignancies

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor for which
no curative or effective therapy is available No symptomatic or uncontrolled brain or
leptomeningeal metastases CT scan required if clinical suspicion of CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no
greater than 1.5 times ULN No acute hepatitis Renal: Not specified Cardiovascular: No
unstable cardiac disease No history of cardiac arrhythmia (treated or untreated) No new
onset crescendo or rest angina (stable exertional angina allowed) Pulmonary: Not specified
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception at least 1 week prior to, during, and for at least 2 weeks after study No
known hypersensitivity to fluorouracil-uracil or leucovorin calcium No grade 2 or greater
nausea/vomiting or diarrhea No significant neurological or psychiatric condition,
including psychotic disorders, dementia, or seizures No active serious infection or
septicemia No severe gastrointestinal bleeding No other serious illness or significant
medical condition that would preclude study No psychological, familial, or sociological
condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At
least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and
recovered No more than 1 prior chemotherapy regimen Prior fluorouracil and taxanes allowed
Prior parenteral etoposide allowed Endocrine therapy: No concurrent anti-cancer hormonal
agents Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Prior
radiotherapy to brain metastases allowed if stable neurological status achieved within 4
weeks of treatment No concurrent radiotherapy except for palliation of bone or brain
metastases or pathological fractures of known lytic disease Surgery: Not specified Other:
At least 3 weeks since prior investigational drugs and recovered No other concurrent
anticancer drugs No other concurrent investigational therapy No concurrent halogenated
antiviral agents such as lodenosine, fialuridine, clevudine, emtricitabine, or sorivudine
No concurrent antiarrhythmic medication