Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Doxorubicin Hydrochloride Liposome or Capecitabine as First-Line Chemotherapy in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 18 and over Other, Pharmaceutical / Industry SPRI-P04445 EU-20654, NCT00266799, SPRI-PELICAN

Objectives

1. Compare time to disease progression in women with metastatic breast cancer treated with doxorubicin hydrochloride liposome versus capecitabine as first-line chemotherapy.
2. Compare overall response rate, time to treatment failure, and overall survival.
3. Compare safety and tolerability.
4. Compare quality of life.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed breast cancer



• Metastatic disease



• Evaluable disease, defined as at least one unidimensionally measurable lesion, according to the RECIST criteria, in at least one site that has not been irradiated
  • Patients who only have evaluable/nonmeasurable disease are eligible
  • Bone-only metastasis allowed



• No anthracycline-resistant disease, as defined by either of the following:
  • Developed locally recurrent or metastatic disease while on adjuvant anthracycline therapy
  • Disease relapsed < 6 months after completion of anthracycline therapy



• No evidence of primary or metastatic malignancy involving the CNS, unless previously treated and asymptomatic for ≥ 3 months



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior therapy for metastatic breast cancer
  • Prior hormonal therapy in the metastatic or adjuvant setting allowed
  • Prior chemotherapy in the adjuvant setting allowed
• No prior capecitabine or doxorubicin hydrochloride liposome in the adjuvant setting
  • Prior anthracyclines other than doxorubicin hydrochloride liposome in the adjuvant setting allowed provided treatment was completed > 6 months ago
• At least 30 days since prior participation in a clinical study
• No other concurrent participation in a clinical study
• No other concurrent therapy for metastatic disease, including hormonal therapy, radiotherapy, trastuzumab (Herceptin^®) or other biologicals
  • Concurrent bisphosphonates allowed

Patient Characteristics:

• Female
• Menopausal status not specified
• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• WBC ≥ 3,500/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 3 times ULN (5 times ULN if related to liver metastasis)
• Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min and creatinine ≤ 1.8 mg/dL
• Serum electrolytes normal
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 6 months after completion of study therapy
• Must be willing and able to complete study questionnaires
• No dyspnea on exertion
• LVEF ≥ 50%
• No history of cardiac disease, including any of the following:
  • New York Heart Association class II-IV cardiac disease
  • Clinical evidence of congestive heart failure
  • Myocardial infarction within the past 6 months
• No drug, alcohol, or pharmaceutical abuse

Expected Enrollment

A total of 346 patients will be accrued for this study.

Outcomes

Time to disease progression
Overall response rate
Overall survival
Quality of life
Time to treatment failure
Safety
Tolerability

Outline

This is a multicenter, open-label, controlled, randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive doxorubicin hydrochloride liposome.



• Arm II: Patients receive capecitabine.

Trial Contact Information

Trial Lead Organizations

Schering-Plough Research Institute

Nadia Harbeck, MD, Protocol chair		Ph: 49-89-4140-5419 Email: nadia.harbeck@lrz.tum.de

U.S.A.
New Jersey
	Kenilworth
	Schering-Plough Research Institute
		Clinical Trials Office - Schering-Plough Research Institute	Ph:  908-740-4531
Australia
New South Wales
	Westmead
	Westmead Institute for Cancer Research at Westmead Hospital
		Contact Person	Ph:  61-2-9845-9000
Victoria
	Malvern
	Cabrini Hospital
		Contact Person	Ph:  61-3-9508-1222
Denmark
	Herlev
	Herlev University Hospital
		Contact Person	Ph:  45-4488-4488
	Naestved
	Naestved Hospital
		Contact Person	Ph:  45-5651-2000
Germany
	Aschaffenburg
	Studien-Zentrum Aschaffenburg
		Contact Person	Ph:  49-6021-342-780
	Bayreuth
	Klinikum Bayreuth
		Contact Person	Ph:  49-921-400-00
	Berlin
	Helios Klinikum Berlin
		Contact Person	Ph:  49-30-9401-7685
	Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum
		Contact Person	Ph:  49-30-5548-9336
	Bonn
	Johanniter-Krankenhaus Bonn
		Contact Person	Ph:  49-228-543-2401
	Cologne
	Universitaetsfrauenklinik - Koeln
		Contact Person	Ph:  49-221-478-4900
	Deggendorf
	Klinikum Deggendorf
		Contact Person	Ph:  49-991-380-3172
	Dresden
	Onkologische Gemeinschaftspraxis
		Contact Person	Ph:  49-351-4796-0368
	Onkologische Gemeinschaftspraxis - Dresden
		Contact Person	Ph:  49-351-849-5071
	Duesseldorf
	Luisenkrankenhaus GmbH & Co. KG
		Contact Person	Ph:  49-211-6992-20
	Erlangen
	Medizinische Klinik III - Universitaetsklinikum Erlangen
		Contact Person	Ph:  49-9131-853-3363
	Essen
	Kliniken Essen Sued
		Contact Person	Ph:  49-201-8408-1280
	Universitaetsklinikum Essen
		Contact Person	Ph:  49-201-723-5922
	Esslingen
	Staedtische Kliniken Esslingen
		Contact Person	Ph:  49-711-3103-3051
	Frankfurt
	Krankenhaus Nordwest
		Contact Person	Ph:  49-69-7601-3380
	Freising
	Gynaekologische Gemeinschaftspraxis - Pause, Thiel & Neuhofer
		Contact Person	Ph:  49-816-192-688
	Goettingen
	Universitaetsklinikum Goettingen
		Contact Person	Ph:  49-551-398-600
	Halle
	Universitaetsklinikum Halle
		Contact Person	Ph:  49-345-557-2457
	Hamburg
	Hamatologische/Onkologische - Hamburg
		Contact Person	Ph:  49-40-3802-1283
	Innovation Onkologie Research and Consulting GmbH
		Contact Person	Ph:  49-40-2260-4650
	University Medical Center Hamburg - Eppendorf
		Contact Person	Ph:  49-404-2803-2960
	Hof
	Onkologische Schwerpunktpraxis Hof
		Contact Person	Ph:  49-9281-540-060
	Jena
	Klinikum der Friedrich-Schiller Universitaet Jena
		Contact Person	Ph:  49-3641-933-114
	Leer
	Onkologische Schwerpunktpraxis - Leer
		Contact Person	Ph:  49-491-987-910
	Lueneburg
	Staedtisches Klinikum Lueneburg
		Contact Person	Ph:  49-4131-77-0
	Magdeburg
	Staedtisches Klinikum Magdeburg
		Contact Person	Ph:  49-391-791-0
	Mainz
	Johannes Gutenberg University
		Contact Person	Ph:  49-61-3117-2683
	Mannheim
	Gemeinschaftspraxis Gynaekologie & Geburtshilfe
		Contact Person	Ph:  49-621-1250-6420
	Muehlhausen
	Brustzentrum Mittelthuerungen
		Contact Person	Ph:  49-3601-758-208
	Munich
	Klinikum Rechts Der Isar - Technische Universitaet Muenchen
		Nadia Harbeck, MD	Ph:  49-89-4140-5419
			Email: nadia.harbeck@lrz.tum.de
	LMU-Klinikum Grosshadern
		Contact Person	Ph:  49-89-7095-3017
	Offenbach
	Klinikum Offenback GmbH
		Contact Person	Ph:  49-69-8405-3362
	Oldenburg
	Onkologische Schwerpunktpraxis
		Contact Person	Ph:  49-441-770-5980
	Singen
	Haematologisch-onkologische Schwerpunktpraxis
		Contact Person	Ph:  49-7731-654-44
	Straubing
	Onkologische Schwerpunktpraxis - Straubing
		Contact Person	Ph:  49-9421-90777
	Tuebingen
	Southwest German Cancer Center at Eberhard-Karls-University
		Contact Person	Ph:  49-7071-292-711
	Ulm
	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
		Contact Person	Ph:  49-731-5005-6056
	Wiesbaden
	Dr. Horst-Schmidt-Kliniken
		Contact Person	Ph:  49-611-432-507
	St. Josefs-Hospital Wiesbaden
		Contact Person	Ph:  49-611-177-0
Spain
	Barcelona
	Hospital Del Mar
		Contact Person	Ph:  34-93-248-3000
	Cordoba
	Hospital Universarito Reina Sofia
		Contact Person	Ph:  34-95-701-0380
	Sabadell
	Consorci Hospitalari del Parc Tauli
		Contact Person	Ph:  34-93-723-1010
	Santiago de Compostela
	Santiago de Compostela University Hospital
		Contact Person	Ph:  34-98-195-0000
	Sevilla
	Hospital Universidad Virgen Del Rocio
		Contact Person	Ph:  34-95-501-3068
	Valencia
	Hospital Clinico Universitario de Valencia
		Contact Person	Ph:  34-96-386-2625
	Hospital Universitario La Fe
		Contact Person	Ph:  34-96-386-2700
	Zaragoza
	Hospital Universitario Miguel Servet
		Contact Person	Ph:  34-97-676-5510
Turkey
	Ankara
	Hacettepe University - Faculty of Medicine
		Contact Person	Ph:  90-312-305-1080
	Izmir
	Dokuz Eylul University School of Medicine
		Contact Person	Ph:  90-232-259-8774

Registry Information
Official Title		The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer [PELICAN]
Trial Start Date		2007-01-02
Registered in ClinicalTrials.gov		NCT00266799
Date Submitted to PDQ		2007-01-16
Information Last Verified		2008-04-02