Trials / Completed
CompletedNCT00005980
Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.
Detailed description
OBJECTIVES: * Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome. * Assess the side effects of these treatment regimens in this patient population. * Determine the duration of response in these patients treated with these regimens. * Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks. * Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks. Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pegylated liposomal doxorubicin hydrochloride |
Timeline
- Start date
- 2000-04-01
- Primary completion
- 2002-07-01
- First posted
- 2003-01-27
- Last updated
- 2012-07-18
Locations
14 sites across 9 countries: Austria, France, Greece, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00005980. Inclusion in this directory is not an endorsement.