Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

NCT00005980 | Completed Phase 2

• 4 other identifiers: EORTC-10993-16998EORTC-IDBBC-10993ECSG-10993PAMM-10993
• Study Type: interventional
• Target: 116
• Locations: 9 countries
• Sites: 14

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

pegylated liposomal doxorubicin hydrochloride DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (14)

Ludwig Boltzmann - Institute for Applied Cancer Research

Vienna, A-1100, Austria

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

University of Ioannina

Ioannina, GR-45110, Greece

Location

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100, Israel

Location

Mario Negri Institute for Pharmacological Research

Milano (Milan), 20157, Italy

Location

Istituti Fisioterapici Ospitalieri - Roma

Rome, 00161, Italy

Location

Academisch Ziekenhuis Groningen

Groningen, 9713 EZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Clinique De Genolier

Genolier, Ch-1272, Switzerland

Location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 17116400 BACKGROUND

• 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.

  PMID: 16520033 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: April 1, 2000
• Primary Completion: July 1, 2002
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

IL (1); GR (1); ES (1); NL (2); AU (1); GB (1); CH (1); FR (4); IT (2)