Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
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.
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer|
|Study Start Date:||April 2000|
|Primary Completion Date:||July 2002 (Final data collection date for primary outcome measure)|
- 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.
|Ludwig Boltzmann - Institute for Applied Cancer Research|
|Vienna, Austria, A-1100|
|Bordeaux, France, 33076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Institut Curie - Section Medicale|
|Paris, France, 75248|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|University of Ioannina|
|Ioannina, Greece, GR-45110|
|Rabin Medical Center - Beilinson Campus|
|Petah-Tikva, Israel, 49100|
|Mario Negri Institute for Pharmacological Research|
|Milano (Milan), Italy, 20157|
|Istituti Fisioterapici Ospitalieri - Roma|
|Rome, Italy, 00161|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9713 EZ|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Clinique De Genolier|
|Genolier, Switzerland, Ch-1272|
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Study Chair:||Robert E. Coleman, MD, FRCP||Cancer Research Centre at Weston Park Hospital|
|Study Chair:||Maurizio D'Incalci, MD||Mario Negri Institute for Pharmacological Research|
|Study Chair:||Christian Dittrich, MD||Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital|