Analyses of Human Samples Collected in Clinical Trials

Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile,
and/or saliva) will be collected from cancer patients enrolled on approved clinical trials,
in accordance with the local protocol. These trials are being conducted at outside
institutions, in collaboration with the National Cancer Institute (NCI) and the samples will
be sent to the NCI for pharmacological analysis, involving determination of parent drug
and/or metabolite concentrations and subsequent pharmacokinetics and statistical data
analysis. This study aims to further characterize the clinical pharmacokinetic behavior of
select cancer therapeutics. Future collaborators will be added via the protocol amendment
procedure.

- INCLUSION CRITERIA:

Any patients entered on approved trials of cancer therapeutics or agents that are commonly
administered to patients with cancer at institutions outside of the intramural NCI are
eligible for inclusion, provided that they have consented to pharmacological analysis in
the original consent form.

EXCLUSION CRITERIA:

None anticipated at this time.