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An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women With Metastatic Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sandy Marcus

Investigator Role:

Study Chair

Investigator Affiliation:

Pharmatech Oncology

Authority:

United States: Federal Government

Study ID:

CDR0000069104

NCT ID:

NCT00027989

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Montgomery Cancer CenterMontgomery, Alabama  36106-3657
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Oncology-Hematology Associates, P.A.Clinton, Maryland  20735
California Cancer Medical CenterWest Covina, California  91790
Pharmatech OncologyDenver, Colorado  80203