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Home > "G" Clinical Trials Conditions > Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer



Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and liposomal doxorubicin in treating women who have metastatic breast cancer.
Details: OBJECTIVES: I. Determine the objective response rate, duration of response, time to disease progression, and duration of survival of women with metastatic breast cancer when treated with gemcitabine and doxorubicin HCl liposome. II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this treatment regimen in these patients. PROTOCOL OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and doxorubicin HCl liposome IV over 2.5 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 20 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic breast cancer - Bidimensionally measurable disease - No uncontrolled brain metastases or leptomeningeal disease - Brain metastases treated with surgery and/or radiotherapy allowed if neurologic status is stable two weeks after last dose of dexamethasone - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No prior high-dose chemotherapy followed by bone marrow transplantation - Chemotherapy: See Biologic Therapy; At least 3 weeks since prior chemotherapy and recovered; No prior doxorubicin HCl liposome or gemcitabine; Prior neoadjuvant chemotherapy allowed; At least 12 months since prior adjuvant anthracycline-based therapy and no evidence of anthracycline resistance (i.e., developed progressive disease while receiving adjuvant therapy or within 6 months of completing adjuvant therapy); Prior mitoxantrone allowed if total dose was no greater than 105 mg/m2 IV bolus or 140 mg/m2 IV continuous infusion; Prior doxorubicin allowed if total dose was no greater than 300 mg/m2 IV bolus or 400 mg/m2 IV continuous infusion; No prior chemotherapy for metastatic disease - Endocrine therapy: Prior adjuvant and/or palliative hormonal therapy allowed - Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy and recovered - Surgery: See Disease Characteristics; Prior surgery allowed - Other: At least 3 weeks since prior investigational study; Concurrent pamidronate allowed if bone not the only site of disease --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: Zubrod 0-2 - Life expectancy: At least 3 months - Hematopoietic: Platelet count at least 100,000/mm3; Hemoglobin at least 8 g/dL; Absolute neutrophil count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.2 mg/dL; SGPT less than 1.5 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: LVEF at least 50% by MUGA; No cardiac disease or congestive heart failure - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other concurrent serious illness, psychiatric disorder, or active infection; No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
EdgardoRivera,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4009
United States
 


Additional Information:
Study ID Numbers:  CDR0000067980;  MDA-DM-97127,NCI-1650
Study Start Date: April 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005991

Other Stage 4 Breast Cancer Studies:
1. Bexarotene in Treating Patients With Metastatic Breast Cancer

2. Biological Therapy in Treating Women With Stage IV Breast Cancer

3. Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases

4. Positron Emission Tomography Before Surgery in Evaluating Women With Primary or Recurrent Breast Cancer

5. Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy

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