Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00005980
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2000-04-30
Brief Summary
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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
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* 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
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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pegylated liposomal doxorubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically proven progressive or recurrent metastatic breast cancer
* Bidimensionally measurable disease with at least one target lesion
* If previously irradiated lesions:
* No preirradiated only lesions
* Clear progression prior to study
* New lesions in a previously irradiated region allowed
* Refusal of or medical contraindication to standard anthracycline containing regimen
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Any age
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* Transaminases less than 2 times upper limit of normal
Renal:
* Creatinine normal
Cardiovascular:
* Left ventricular ejection fraction normal by echocardiography or MUGA scan
* No significant cardiac history including:
* Clinically significant atrial or ventricular arrhythmias requiring treatment
* Medically controlled congestive heart failure
* Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year
* Clinically significant valvular disease
Other:
* No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m\^2, and total mitoxantrone dose is no greater than 75 mg/m\^2
* No greater than one regimen of prior chemotherapy for metastatic disease
* No prior anthracyclines for metastatic disease
* No other concurrent cytotoxic therapy
Endocrine therapy:
* No concurrent hormonal therapy
* At least 4 weeks since prior progestins, estrogens, or androgens
Radiotherapy:
* See Disease Characteristics
* Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field
Surgery:
* Not specified
Other:
* Concurrent bisphosphonates for metastatic bone disease and hypercalcemia secondary to malignancy allowed if bony lesions not only target lesion
* No other concurrent investigational therapy
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Robert E. Coleman, MD, FRCP
Role: STUDY_CHAIR
Cancer Research Centre at Weston Park Hospital
Maurizio D'Incalci, MD
Role: STUDY_CHAIR
Mario Negri Institute for Pharmacological Research
Christian Dittrich, MD
Role: STUDY_CHAIR
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
Locations
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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
Countries
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References
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Biganzoli L, Coleman R, Minisini A, Hamilton A, Aapro M, Therasse P, Mottino G, Bogaerts J, Piccart M. A joined analysis of two European Organization for the Research and Treatment of Cancer (EORTC) studies to evaluate the role of pegylated liposomal doxorubicin (Caelyx) in the treatment of elderly patients with metastatic breast cancer. Crit Rev Oncol Hematol. 2007 Jan;61(1):84-9. doi: 10.1016/j.critrevonc.2006.07.008. Epub 2006 Nov 20.
Coleman RE, Biganzoli L, Canney P, Dirix L, Mauriac L, Chollet P, Batter V, Ngalula-Kabanga E, Dittrich C, Piccart M. A randomised phase II study of two different schedules of pegylated liposomal doxorubicin in metastatic breast cancer (EORTC-10993). Eur J Cancer. 2006 May;42(7):882-7. doi: 10.1016/j.ejca.2005.12.011. Epub 2006 Mar 7.
Other Identifiers
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EORTC-IDBBC-10993
Identifier Type: -
Identifier Source: secondary_id
ECSG-10993
Identifier Type: -
Identifier Source: secondary_id
PAMM-10993
Identifier Type: -
Identifier Source: secondary_id
EORTC-10993-16998
Identifier Type: -
Identifier Source: org_study_id