Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer

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

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 liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: gemcitabine hydrochloride; Drug: pegylated liposomal doxorubicin hydrochloride

Detailed Description

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Pharmatech Oncology
• Investigators: Study Chair: Sandy Marcus, Pharmatech Oncology

Study record dates

Study Major Dates

• Study Start: December 1, 2001

Study Registration Dates

• First Submitted: December 7, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: April 1, 2004

More Information

Terms related to this study

• Keywords: stage IV breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Gemcitabine; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: CDR0000069104; PHARMATECH-P01-00002008; ORTHO-PHARMATECH-P01-000020008; PHARMATECH-20002183