Spots Global Cancer Trial Database for Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
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Trial Identification
Brief Title: Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
Official Title: A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer
Study ID: NCT00005980
Conditions
Interventions
Study Description
Brief 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Ludwig Boltzmann - Institute for Applied Cancer Research, Vienna, , Austria
Institut Bergonie, Bordeaux, , France
Centre Jean Perrin, Clermont-Ferrand, , France
Institut Curie - Section Medicale, Paris, , France
Centre Henri Becquerel, Rouen, , France
University of Ioannina, Ioannina, , Greece
Rabin Medical Center - Beilinson Campus, Petah-Tikva, , Israel
Mario Negri Institute for Pharmacological Research, Milano (Milan), , Italy
Istituti Fisioterapici Ospitalieri - Roma, Rome, , Italy
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Hospital Universitario 12 de Octubre, Madrid, , Spain
Clinique De Genolier, Genolier, , Switzerland
Royal Marsden NHS Trust, London, England, United Kingdom
Contact Details
Name: Robert E. Coleman, MD, FRCP
Affiliation: Cancer Research Centre at Weston Park Hospital
Role: STUDY_CHAIR
Name: Maurizio D'Incalci, MD
Affiliation: Mario Negri Institute for Pharmacological Research
Role: STUDY_CHAIR
Name: Christian Dittrich, MD
Affiliation: Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Role: STUDY_CHAIR
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