Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or clinically confirmed metastatic or unresectable solid tumor for
which no standard curative or palliative therapy exists or is no longer

- No known brain 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 normal

- Proven Gilbert's syndrome (UGT1A1 promoter mutation or clinical

- documentation of stress bilirubin levels) allowed

- AST/ALT no greater than 3 times upper limit of normal

Renal:

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Pulmonary:

- No unexplained respiratory problems (e.g., nonproductive cough, dyspnea,

- rales, pulmonary infiltrates, hypoxia, or tachypnea)

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No clinical evidence of neuropathy

- No prior allergy to platinum compounds

- No prior allergy to antiemetics appropriate for administration in

- conjunction with protocol directed chemotherapy

- No other concurrent uncontrolled illness (e.g., active infection)

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and

- platinum) and recovered

- No more than 1 prior chemotherapy regimen for cancer

Radiotherapy:

- At least 4 weeks since prior radiotherapy

Other:

- No concurrent antiretroviral agents (HAART)

- No other concurrent investigational agents or commercial therapies