RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of combining liposomaldoxorubicin with gemcitabine in treating women who have metastatic breast cancer.

Condition	Treatment or Intervention	Phase
stage IV breast cancer	Drug: doxorubicin HCl liposome  Drug: gemcitabine  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the objective response rate in women with metastatic breast cancer treated with doxorubicin HCl liposome and gemcitabine.
• Determine the duration of response, time to disease progression, and duration of survival of patients treated with this regimen.
• Determine the quality of life of patients treated with this regimen.
• Determine the quantitative toxicity of this regimen, in terms of incidence, type, and severity, in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 courses beyond documentation of CR.

Quality of life is assessed at baseline, on day 1 of each course, and then at the end of study.

Patients are followed at 4 weeks and then every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic breast cancer
• Measurable disease
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9 g/dL
• Absolute neutrophil count at least 1,500/mm^3
• No impaired bone marrow function

Hepatic:

• Bilirubin no greater than 2 mg/dL
• AST and ALT no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN (unless attributed to tumor)
• No impaired hepatic function

Renal:

• Creatinine no greater than 2.5 mg/dL OR
• Creatinine clearance at least 60 mL/min
• No impaired renal function

Cardiovascular:

• No prior cardiac disease within the past 5 years OR
• LVEF at least 50%

Other:

• No prior uncontrolled seizures
• No uncontrolled systemic infection
• No anthracycline resistance
• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior trastuzumab (Herceptin)

Chemotherapy:

• Prior adjuvant therapy with anthracycline of no more than 320 mg/m^2 allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to more than 1/3 of hematopoietic sites

Surgery:

• Not specified

Other:

• At least 30 days since prior investigational medications and recovered
• No more than 1 prior treatment regimen for metastatic disease

Alabama
      Montgomery Cancer Center, Montgomery,  Alabama,  36106,  United States
California
      California Cancer Medical Center, West Covina,  California,  91790,  United States
Colorado
      Pharmatech Oncology, Denver,  Colorado,  80203,  United States
Maryland
      Oncology-Hematology Associates, P.A., Clinton,  Maryland,  20735,  United States
South Carolina
      South Carolina Oncology Associates, Columbia,  South Carolina,  29201,  United States
      South Carolina Oncology Associates, Columbia,  South Carolina,  29203,  United States

Study chairs or principal investigators

Sandy Marcus,  Study Chair,  Pharmatech Oncology   

Study ID Numbers:  CDR0000069104; PHARMATECH-P01-00002008; ORTHO-PHARMATECH-P01-000020008; PHARMATECH-20002183
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027989
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08