NCT00324610

Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (planned)
• Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity. Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen. Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen

Conditions

• Breast Neoplasms
• Chemotherapy

Interventions

Type	Name	Description
DRUG	capecitabine

Timeline

• Start date: 2006-03-01
• First posted: 2006-05-11
• Last updated: 2006-05-18

Locations

1 site across 1 country: France