Know Cancer

or
forgot password

A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Robert E. Coleman, MD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Research Centre at Weston Park Hospital

Authority:

United States: Federal Government

Study ID:

EORTC-10993-16998

NCT ID:

NCT00005980

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location