Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00004207|
Recruitment Status : Unknown
Verified July 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 9, 2004
Last Update Posted : June 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: liposomal daunorubicin citrate||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study to Determine the Maximum Tolerated Dose of Daunoxome as Therapy for the Treatment of Metastatic Breast Cancer|
|Study Start Date :||December 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004207
|Leicester Royal Infirmary NHS Trust|
|Leicester, England, United Kingdom, LE1 5WW|
|Study Chair:||Kenneth O'Byrne, MD||University Hospitals, Leicester|