Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004207
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2000-01-21
Brief Title:
Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study to Determine the Maximum Tolerated Dose of Daunoxome as Therapy for the Treatment of Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2000-07
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 Phase I trial to study the effectiveness of liposomal daunorubicin in treating patients who have metastatic breast cancer
PURPOSE Phase I trial to study the effectiveness of liposomal daunorubicin in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of daunorubicin liposomal in patients with metastatic breast cancer II Assess the antineoplastic activity and safety profile of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive daunorubicin liposomal IV over a minimum of 2 hours on day 1 Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of daunorubicin liposomal until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity Patients with stable or responding disease are followed at 1 and 3 months then every 3 months for 1 year
PROJECTED ACCRUAL Approximately 15-20 patients will be accrued for this study within 1 year
OUTLINE This is a dose escalation study Patients receive daunorubicin liposomal IV over a minimum of 2 hours on day 1 Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of daunorubicin liposomal until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity Patients with stable or responding disease are followed at 1 and 3 months then every 3 months for 1 year
PROJECTED ACCRUAL Approximately 15-20 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 |
|---|---|---|---|
| EU-99033 | None | None | None |
| LRI-103-UK-V11 | None | None | None |