Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068588
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2003-09-10
Brief Title:
GTI-2040 and Capecitabine in Treating Patients With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of GTI-2040 NSC 722929 in Combination With Capecitabine in Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase II trial is studying how well giving GTI-2040 together with capecitabine works in treating patients with metastatic breast cancer Drugs used in chemotherapy such as capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die GTI-2040 may help capecitabine kill more tumor cells by making them more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response rate and response duration to combination therapy with GTI-2040 and capecitabine in the treatment of metastatic breast cancer
II To safely evaluate the toxicity of this drug combination and schedule in this patient population by first using a lower dose followed by escalation
III To determine pharmacokinetic data on plasma levels of GTI-2040 in this patient population
IV To investigate potential molecular markers of ribonucleotide reductase inhibition and fluoropyrimidine metabolism in this patient population treated with the combination of GTI-2040 and capecitabine
OUTLINE This is a multicenter study
Patients receive GTI-2040 IV continuously on days 1-15 of the first course and days 1-14 of all subsequent courses Patients also receive oral capecitabine twice daily on days 2-15 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I To evaluate the response rate and response duration to combination therapy with GTI-2040 and capecitabine in the treatment of metastatic breast cancer
II To safely evaluate the toxicity of this drug combination and schedule in this patient population by first using a lower dose followed by escalation
III To determine pharmacokinetic data on plasma levels of GTI-2040 in this patient population
IV To investigate potential molecular markers of ribonucleotide reductase inhibition and fluoropyrimidine metabolism in this patient population treated with the combination of GTI-2040 and capecitabine
OUTLINE This is a multicenter study
Patients receive GTI-2040 IV continuously on days 1-15 of the first course and days 1-14 of all subsequent courses Patients also receive oral capecitabine twice daily on days 2-15 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000327757 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62209 |
| PHII-46 | None | None | None |
| N01CM62209 | NIH | None | None |