A Phase I Study of Oxaliplatin in Adult Cancer Patients With Impaired Renal Function

Inclusion Criteria

Patients must have histologically confirmed malignancy which is metastatic or unresectable
and for which standard curative or palliative measures do not exist or are no longer
effective.

Patients with prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy
are allowed with the exception that patients cannot have had prior treatment with
oxaliplatin.

Patients greater than or equal to 18 years of age.

Patients must have an ECOG performance status less than or equal to 2 (Karnofsky greater
than or equal to 60 percent) and a life expectancy of at least 3 months.

Patients must have adequate organ and marrow function which includes:

Leukocytes must be greater than or equal to 3,000/microliter.

Absolute neutrophil count must be greater than or equal to 1,500/microliter.

Platelet count must be greater than or equal to 100,000/microliter.

Total bilirubin within normal institutional limits.

AST (SGOT)/ALT(SGPT) less than or equal to 1.5 times the upper limit of normal.

Patients with no evidence of clinically significant neuropathy.

Women of child-bearing potential and men must agree to use adequate contraception.

Patients must have the ability to understand and the willingness to sign a written
informed consent document.

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the
study, or within 6 weeks of prior platinum therapy will be excluded.

Patients undergoing therapy with other investigational agents will be excluded.

Patients with known brain metastaseswill be excluded.

Patients with a history of an allergy to platinum compounds will be excluded.

Patients with uncontrolled intercurrent illness including but not limited to ongoing or
active infection, symptomatic congestive heart failure, or unstable angina pectoris, or
cardiac arrhythmia will be excluded.

Women must not be pregnant or nursing.

Patients must not be HIV-positive or receiving anti-retroviral therapy (HAART).

Patients actively receiving renal dialysis treatments while on the study will be excluded.