Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418028
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2007-01-03
Brief Title:
Standard Versus Continuous Capecitabine in Advanced Breast Cancer
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Randomized Phase II Trial of Continuous Versus Standard Capecitabine in Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Capecitabine is active in metastatic breast cancer but the conventional schedule 1250 mgm212 hr 2 weeks on one week off produces grade 2 or greater hand and foot syndrome in up to 50 of patients leading to those reductions There are theoretical reasons to administer S-phase specific agents in continuous protracted rather than intermittent schedules The investigators study compares the standard schedule 1250 mgm212 hr 2 weeks on one week off with a continuous administration schedule 800 mgm212hr The latter administer approximately the same cumulative dose of capecitabine as the standard schedule The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50 standard arm to 20 experimental arm The investigators assume similar antitumor activity in both arms
Detailed Description:
Capecitabine is active in metastatic breast cancer but the conventional schedule 1250 mgm212 hr 2 weeks on one week off produces grade 2 or greater hand and foot syndrome in up to 50 of patients leading to those reductions Some authors have tested continuous administration schedules of capecitabine showing better tolerance and apparently similar antitumor activity Capecitabine is a pro-drug of 5-FU and mimics an iv continuous infusion administration of this antimetabolite On the other hand there are theoretical reasons to administer S-phase specific agents in continuous protracted rather than intermittent schedules Our study compares the standard schedule1250 mgm212 hr 2 weeks on one week offwith a continuous administration schule 800 mgm212hr The latter schedule administer approximately the same cumulative dose of capecitabine as the standard one The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50 standard arm to 20 experimental arm The investigators assume similar antitumor activity in both arms
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-002759-15 | EUDRACT_NUMBER | None | None |