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Home > "L" Clinical Trials Conditions > Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer  Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer
Status: Recruiting
Sponsor(s): Pharmatech Oncology ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SandyMarcus, Study Chair, Pharmatech Oncology
Oncology-Hematology Associates, P.A. *Recruiting*
Clinton, Maryland, 20735
United States
Recruiting Harvey Katzen 301-868-7911
South Carolina Oncology Associates *Recruiting*
Columbia, South Carolina, 29203
United States
Recruiting Neal Christiansen 803-434-3650
South Carolina Oncology Associates *Recruiting*
Columbia, South Carolina, 29201
United States
Recruiting Robert Smith 803-296-8957
Pharmatech Oncology *Recruiting*
Denver, Colorado, 80203
United States
Recruiting Sandy Marcus 720-917-7482
California Cancer Medical Center *Recruiting*
West Covina, California, 91790
United States
Recruiting Cary Presant 626-856-5858
Montgomery Cancer Center *Recruiting*
Montgomery, Alabama, 36106
United States
Recruiting Keith Thompson 334-273-2259
Additional Information:
Study ID Numbers: CDR0000069104; ORTHO-PHARMATECH-P01-000020008,PHARMATECH-20002183,PHARMATECH-P01-00002008
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027989
Other Stage 4 Breast Cancer Studies:
1. Tipifarnib and Fulvestrant as Second-Line Therapy in Treating Postmenopausal Women With Hormone Receptor-Positive Inoperable Locally Advanced or Metastatic Breast Cancer With Progressive Disease After Previous First-Line Endocrine Therapy
2. Chemotherapy and Peripheral Stem Cell Transplantation Followed by Trastuzumab in Treating Women With Metastatic Breast Cancer
3. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
4. PS-341 in Treating Women With Metastatic Breast Cancer
5. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other California Clinical Trials
Other West Covina Clinical Trials
Liposomal Doxorubicin and Gemcitabine in Treating Women With Metastatic Breast Cancer
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