Solid Tumors Clinical Trial
Official title:
A Phase I Study of Capecitabine In Patients With Solid Tumors
Hypothesis:
Patients with TYMS 2R/2R or 2R/3R appear to be more sensitive to fluoropyrimidines,
conferring a higher risk of grade 3-4 fluoropyrimidine related toxicity and a higher
response rate compared with 3R/3R. The genotype 3R/3R is more common in East Asia and is
associated with greater tolerability to fluoropyrimidine as measured by lower toxicity but
also lower response rates. As sensitivity to fluoropyrimidine appears to be affected by TYMS
genotype, we hypothesise that patients with TYMS 3R/3R are more tolerant to standard doses
of capecitabine and require higher doses to overcome fluoropyrimidine resistance. We
designed this study to develop TYMS genotype specific dosing of capecitabine.
Aims:
1. To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks
followed by one week rest period (intermittent schedule) in patients with the advanced/
and or metastatic cancer based on TYMS genotype.
2. To determine a suitable phase II dose of intermittent schedule capecitabine.
3. To determine the safety and toxicity of this regimen.
4. To perform plasma pharmacokinetics of capecitabine.
5. To determine the relationship between genes of relevance in the fluoropyrimidine
pathway with pharmacokinetics and toxicity.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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