Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003253
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
Sponsor:
Oncotech
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Assessment of the Predictive Value of the Extreme Drug Resistance EDR Assay in Patients Receiving Paclitaxel for Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-05
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 Some patients may develop a resistance to chemotherapy drugs
PURPOSE Phase II trial to determine the reliability of a test for measuring drug resistance to paclitaxel in patients with metastatic breast cancer
PURPOSE Phase II trial to determine the reliability of a test for measuring drug resistance to paclitaxel in patients with metastatic breast cancer
Detailed Description:
OBJECTIVES I Evaluate the proportion of patients with extreme intermediate and low drug resistance to paclitaxel using the Extreme Drug Resistance EDR Assay in patients with previously treated metastatic breast cancer II Assess response to paclitaxel therapy in patients who have undergone a pretreatment EDR assay III Assess time to tumor progression during paclitaxel therapy in patients who have undergone a pretreatment EDR assay IV Determine prospectively the predictive value of the EDR assay relative to clinical outcome by correlating assay results with clinical tumor response and time to tumor progression during paclitaxel therapy in these patients
OUTLINE This is an open label single arm blinded study Patients tumor tissue samples are collected by excisional biopsy core biopsy or malignant fluid aspiration then tested by the Extreme Drug Resistance EDR Assay to determine probability of drug resistance to paclitaxel After successful completion of the EDR assay approximately 7 days patients receive paclitaxel by intravenous infusion over 1-3 hours treatment is repeated every 3 weeks Treatment continues until there is documented evidence of tumor progression or unacceptable toxicity Patients clinical response to paclitaxel therapy is compared with the response predicted by the EDR assay
PROJECTED ACCRUAL 100 patients will be accrued to this study
OUTLINE This is an open label single arm blinded study Patients tumor tissue samples are collected by excisional biopsy core biopsy or malignant fluid aspiration then tested by the Extreme Drug Resistance EDR Assay to determine probability of drug resistance to paclitaxel After successful completion of the EDR assay approximately 7 days patients receive paclitaxel by intravenous infusion over 1-3 hours treatment is repeated every 3 weeks Treatment continues until there is documented evidence of tumor progression or unacceptable toxicity Patients clinical response to paclitaxel therapy is compared with the response predicted by the EDR assay
PROJECTED ACCRUAL 100 patients will be accrued to this study
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 |
|---|---|---|---|
| NCI-V98-1391 | None | None | None |
| ONCOTECH-OTBR01 | None | None | None |
| UCIRVINE-97-02 | None | None | None |