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

Alternate Title

Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Pharmaceutical / Industry PHARMATECH-P01-00002008 ORTHO-PHARMATECH-P01-000020008, PHARMATECH-20002183, NCT00027989

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed metastatic breast cancer



• Measurable disease



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy:

• No prior trastuzumab (Herceptin)

Chemotherapy:

• Prior adjuvant therapy with anthracycline of no more than 320 mg/m² 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

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/mm³
• Hemoglobin at least 9 g/dL
• Absolute neutrophil count at least 1,500/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Pharmatech Oncology

Sandy Marcus, Protocol chair		Ph: 720-917-7482

Registry Information
Official Title		An Open-Label, Single-Arm, Phase II Study of Liposomal Doxorubicin (Doxil) and Gemcitabine in the Treatment of Women with Metastatic Breast Cancer
Trial Start Date		2001-12-05
Registered in ClinicalTrials.gov		NCT00027989
Date Submitted to PDQ		2001-10-31
Information Last Verified		2004-04-27

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