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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00005980

Collaborator

(none)

116

Enrollment

Locations

8.3

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: pegylated liposomal doxorubicin hydrochloride	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

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 :

Apr 1, 2000

Actual Primary Completion Date :

Jul 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ludwig Boltzmann - Institute for Applied Cancer Research	Vienna		Austria	A-1100
2	Institut Bergonie	Bordeaux		France	33076
3	Centre Jean Perrin	Clermont-Ferrand		France	63011
4	Institut Curie - Section Medicale	Paris		France	75248
5	Centre Henri Becquerel	Rouen		France	76038
6	University of Ioannina	Ioannina		Greece	GR-45110
7	Rabin Medical Center - Beilinson Campus	Petah-Tikva		Israel	49100
8	Mario Negri Institute for Pharmacological Research	Milano (Milan)		Italy	20157
9	Istituti Fisioterapici Ospitalieri - Roma	Rome		Italy	00161
10	Academisch Ziekenhuis Groningen	Groningen		Netherlands	9713 EZ
11	University Medical Center Nijmegen	Nijmegen		Netherlands	NL-6500 HB
12	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
13	Clinique De Genolier	Genolier		Switzerland	Ch-1272
14	Royal Marsden NHS Trust	London	England	United Kingdom	SW3 6JJ

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

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