Ignite Creation Date:
2024-05-05 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 9:50 AM
Study NCT ID:
NCT00697502
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2008-06-11
Brief Title:
Study of Capecitabine In Patients With Solid Tumors
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
A Phase I Study of Capecitabine In Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis
Patients with TYMS 2R2R or 2R3R 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 3R3R The genotype 3R3R 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 3R3R 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
Patients with TYMS 2R2R or 2R3R 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 3R3R The genotype 3R3R 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 3R3R 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None