Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00027989
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2001-12-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining liposomal doxorubicin with gemcitabine in treating women who have metastatic breast cancer.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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gemcitabine hydrochloride
pegylated liposomal doxorubicin hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Pharmatech Oncology
INDUSTRY
Principal Investigators
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Sandy Marcus
Role: STUDY_CHAIR
Pharmatech Oncology
Locations
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Montgomery Cancer Center
Montgomery, Alabama, United States
California Cancer Medical Center
West Covina, California, United States
Pharmatech Oncology
Denver, Colorado, United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Countries
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Other Identifiers
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PHARMATECH-P01-00002008
Identifier Type: -
Identifier Source: secondary_id
ORTHO-PHARMATECH-P01-000020008
Identifier Type: -
Identifier Source: secondary_id
PHARMATECH-20002183
Identifier Type: -
Identifier Source: secondary_id
CDR0000069104
Identifier Type: -
Identifier Source: org_study_id