Oxaliplatin to Treat Advanced Cancers With Liver Dysfunction
Liver Disease
About this trial
This is an interventional treatment trial for Liver Disease focused on measuring Liver Impairment, Pharmacokinetics, Platinum Analogues
Eligibility Criteria
Must have histologically confirmed malignancy which is metastatic or unresectable and for which standard curative or palliative treatments do not exist or are no longer effective. Must have had 3 or fewer previous regimens (may have included prior platinum therapy). Previous radiation allowed but should have included less than or equal to 30% of bone marrow. At least 18 years old. Karnofsky performance status greater than or equal to 60%. Patients should have an expected survival of at least 2 months. Leukocytes greater than or equal to 3,000/micro liter; or absolute neutrophil count greater than or equal to 1,500/micro liter; or platelets greater than or equal to 100,000/micro liter, creatinine within normal institutional limits; or measured creatinine clearance greater than or equal to 60 mL/min for patients with creatinine levels above institutional normal. Abnormal liver function is acceptable. Biliary obstruction for which a shunt has been placed is acceptable provided the shunt is in place for at least 10 days prior to the first dose of oxaliplatin to allow the liver function tests to stabilize. No evidence of clinically significant neuropathy. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Breastfeeding should be discontinued if the mother is treated with oxaliplatin. Must be able to understand and willing to sign a written informed consent document. No chemotherapy or radiotherapy within 4 weeks prior to entering the study and no platinum therapy within 6 weeks prior to entering the study. Not undergoing therapy with other investigational agents. No known brain metastases. No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. No uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia. No HIV-positive patients receiving anti-retroviral therapy (HAART). No known allergy to erythromycin or indocyanine green.
Sites / Locations
- National Cancer Institute (NCI)