Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083148
Status:
COMPLETED
Last Update Posted:
2011-03-09
First Post:
2004-05-14
Brief Title:
Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Phase I Study of Irinotecan Followed by Capecitabine in Patients With Advanced Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2011-03
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:
RATIONALE Drugs used in chemotherapy such as irinotecan and capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Irinotecan may help capecitabine kill more tumor cells by making tumor cells more sensitive to the drug
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer
PURPOSE This phase I trial is studying the side effects and best dose of irinotecan and capecitabine in treating women with advanced breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer
Determine the degree of accumulation of cells in S-phase in tumor biopsies from patients treated with this regimen
Determine the dose-limiting toxicity and other major or unusual toxic effects of this regimen in these patients
Determine any antitumor activity of this regimen in these patients
Determine the pharmacokinetics of this regimen including the active metabolite SN-38 in these patients
Correlate pharmacokinetic parameters of this regimen with the biological changes observed in these patients
Determine preliminarily the relationship of tumor response with modulation of S-phase in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive irinotecan IV over 15 hours on days 1 8 22 and 29 and oral capecitabine twice daily on days 1-14 and 23-36 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 8-37 patients will be accrued for this study within 18-24 months
Determine the maximum tolerated dose of capecitabine and irinotecan in women with advanced breast cancer
Determine the degree of accumulation of cells in S-phase in tumor biopsies from patients treated with this regimen
Determine the dose-limiting toxicity and other major or unusual toxic effects of this regimen in these patients
Determine any antitumor activity of this regimen in these patients
Determine the pharmacokinetics of this regimen including the active metabolite SN-38 in these patients
Correlate pharmacokinetic parameters of this regimen with the biological changes observed in these patients
Determine preliminarily the relationship of tumor response with modulation of S-phase in patients treated with this regimen
OUTLINE This is a dose-escalation study
Patients receive irinotecan IV over 15 hours on days 1 8 22 and 29 and oral capecitabine twice daily on days 1-14 and 23-36 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 8-37 patients will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| RPCI-RP-0221 | None | None | None |