Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026442
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-11-09
Brief Title:
Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
Sponsor:
Pharmatech Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Trial Of Two Different Doses Of Capecitabine XELODA In Patients With Advanced AndOr Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2004-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Compare the objective response rate in women with advanced or metastatic breast cancer treated with two dose levels of capecitabine
Compare the duration of response time to progression time to treatment failure survival incidence of adverse events and time to onset of the adverse experience in patients treated with this drug
Compare the quality of life of patients treated with this drug
OUTLINE This is a randomized multicenter study Patients are stratified according to Karnofsky performance status 70-80 vs 90-100 and presence of hepatic metastases yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive lower-dose oral capecitabine twice daily on days 1-14
Arm II Patients receive higher-dose oral capecitabine twice daily on days 1-14
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the end of the third and sixth courses and at completion of therapy
PROJECTED ACCRUAL A total of 120 patients 60 per treatment arm will be accrued for this study within 9 months
Compare the objective response rate in women with advanced or metastatic breast cancer treated with two dose levels of capecitabine
Compare the duration of response time to progression time to treatment failure survival incidence of adverse events and time to onset of the adverse experience in patients treated with this drug
Compare the quality of life of patients treated with this drug
OUTLINE This is a randomized multicenter study Patients are stratified according to Karnofsky performance status 70-80 vs 90-100 and presence of hepatic metastases yes vs no Patients are randomized to one of two treatment arms
Arm I Patients receive lower-dose oral capecitabine twice daily on days 1-14
Arm II Patients receive higher-dose oral capecitabine twice daily on days 1-14
In both arms courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the end of the third and sixth courses and at completion of therapy
PROJECTED ACCRUAL A total of 120 patients 60 per treatment arm will be accrued for this study within 9 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ROCHE-PHARMATECH-XEL-154 | None | None | None |
| PHARMATECH-XEL-154 | None | None | None |
| PHARMATECH-20010330 | None | None | None |