Oxaliplatin to Treat Advanced Cancers With Liver Dysfunction
Status:
Completed
Trial end date:
2001-05-01
Target enrollment:
Participant gender:
Summary
This is a phase I study of the experimental anticancer drug oxaliplatin. It is designed to
establish the maximum dose of the drug that can be given safely to patients with cancer who
have impaired liver function and to determine the drug's side effects. It will also examine
how liver function affects the drug's elimination from the body. The liver plays an important
role in the elimination of many anticancer drugs, and patients with impaired liver function
should not take certain drugs or should take them in reduced doses.
Patients 18 years of age and older with cancer that has metastasized (spread from the
original tumor site) and for whom standard treatment is not available or is no longer
effective may be eligible for this study. Candidates will be screened with various tests and
procedures that may include physical examination, computerized tomography (CT) or magnetic
resonance imaging (MRI) scans, chest X-rays, and blood and urine tests.
Participants will be given oxaliplatin in doses determined according to their level of liver
function. Patients may have normal liver function or mildly, moderately or severely impaired
liver function, or may have had a liver transplant. Oxaliplatin will be infused intravenously
(through a vein) over two hours on the first day of 21-day treatment cycles-that is, once
every 3 weeks. Treatment will continue as long as the cancer is under control and side
effects do not require stopping the drug. Urine will be collected over 48 hours after the
infusion to determine how much of the drug is eliminated in urine. Blood tests will be done
to monitor safety of the treatment, and imaging studies, such as X-rays, CT and MRI scans,
will be done periodically to evaluate the tumor's response to treatment.
Special blood tests will also be done to study how oxaliplatin is eliminated from the body.
With the first dose of the drug, blood samples will be collected just before the infusion
begins, just before it ends, 15 minutes, 30 minutes, 1, 2, 4, 6, 24, 48, and 72 hours after
the infusion, and again 1 week and 3 weeks later. Additional blood samples may be collected
at the third treatment cycle.