Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006007
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2000-07-05
Brief Title:
LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of a Combination of MTA LY231514 and Gemcitabine in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combining LY231514 plus gemcitabine in treating women who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in the treatment of women with metastatic breast cancer who have received an anthracycline and a taxane in the adjuvant andor metastatic setting and no more than 1 chemotherapy regimen for metastatic disease unless these were a taxane and anthracycline
Determine the toxicity of this regimen in this patient population
Determine time to progression and overall survival of these patients receiving this regimen
OUTLINE Patients receive gemcitabine IV over 30 minutes on days 1 and 8 pemetrexed disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8 Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression Patients achieving a complete response receive 2 additional courses
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 1 year
Assess the antitumor activity of pemetrexed disodium in combination with gemcitabine in the treatment of women with metastatic breast cancer who have received an anthracycline and a taxane in the adjuvant andor metastatic setting and no more than 1 chemotherapy regimen for metastatic disease unless these were a taxane and anthracycline
Determine the toxicity of this regimen in this patient population
Determine time to progression and overall survival of these patients receiving this regimen
OUTLINE Patients receive gemcitabine IV over 30 minutes on days 1 and 8 pemetrexed disodium IV is administered over 10 minutes 90 minutes following gemcitabine on day 8 Treatment continues every 21 days for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression Patients achieving a complete response receive 2 additional courses
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000068015 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02348 | REGISTRY | None | None |