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Home > "P" Clinical Trials Conditions > Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer  Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
For Condition: stage 3B breast cancer,stage 4 breast cancer,recurrent breast cancer,stage 3A breast cancer
Status: Completed
Sponsor(s): Eli Lilly and Company ,
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. It is not yet known if paclitaxel is more effective with or without gemcitabine for advanced breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel with or without gemcitabine in treating women who have advanced breast cancer.
Details: OBJECTIVES: I. Compare overall survival of patients with unresectable, locally recurrent, or metastatic breast cancer treated with paclitaxel with or without gemcitabine. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Patients receive paclitaxel with or without gemcitabine. Treatment continues every 21 days in the absence of disease progression. Patients are followed every 2-4 months for 2 years after active treatment. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven unresectable, locally recurrent, or metastatic breast cancer not amenable to surgery or radiotherapy of curative intent - No inflammatory breast cancer unless evidence of metastatic disease - No bone metastases, pleural effusion, or ascites as the only site of disease - Clinically measurable disease outside previously irradiated area - Relapse after 1 prior adjuvant or neoadjuvant chemotherapy regimen containing anthracycline unless clinically contraindicated - No known or suspected brain metastases or recurrence requiring steroids or radiotherapy - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No prior bone marrow transplantation or autologous stem cell infusion following high-dose adjuvant chemotherapy for metastatic disease; No concurrent immunotherapy (including humanized anti-HER2 antibody) - Chemotherapy: See Disease Characteristics; See Biologic therapy; No prior chemotherapy for metastatic breast cancer; No prior gemcitabine or taxane; No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics; Prior antitumoral hormonal therapy allowed; No concurrent hormonal therapy excluding contraceptives and replacement steroids - Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: See Disease Characteristics - Other: Recovered from prior therapy; At least 30 days since prior investigational drugs; No concurrent investigational drugs; Concurrent bisphosphonate therapy allowed if not begun or stopped within 4 weeks before study --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: Karnofsky 70-100% - Life expectancy: At least 12 weeks - Hematopoietic: Absolute granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: ALT and AST no greater than 2 times upper limit of normal (ULN); Bilirubin no greater than 1.5 times ULN - Renal: Calcium no greater than 1.2 times ULN; Creatinine no greater than 1.5 times ULN - Cardiovascular: No active uncontrolled cardiac disease and/or myocardial infarction within the past 6 months - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after completion of study; No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No other serious systemic disorder precluding study; No active infection; No severe psychiatric disease; No history of hypersensitivity reactions to polyoxyethylated castor oil-based drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FurhanYunus, Study Chair, Eli Lilly and Company
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, 28603
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, 38119
United States
APN-IMPATH Research Corporation
Ft. Lee, New Jersey, 07024
United States
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, 38801
United States
University of Tennessee, Memphis
Memphis, Tennessee, 38163
United States
Arlington Cancer Center
Arlington, Texas, 76012
United States
Indiana Community Cancer Care, Inc.
Indianapolis, Indiana, 46202
United States
Little Rock Hematology-Oncology Associates
Little Rock, Arkansas, 72205
United States
St. John's Mercy Medical Center
St. Louis, Missouri, 63141
United States
Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Office of Alex J.P. Makalinao
Los Angeles, California, 90045
United States
Northern Virginia Oncology Group, P.C.
Fairfax, Virginia, 22031
United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, 74104
United States
Office Of C. Michael Jones
Germantown, Tennessee, 38138
United States
Mercy Hospital
Miami, Florida, 33133
United States
Danbury Internal Medicine
Danbury, Connecticut, 06810
United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, 35801
United States
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, 19146
United States
Cancer Health Associates
Michigan City, Indiana, 46360
United States
Hematology/Oncology Group
Santa Rosa, California, 95403
United States
Memorial Medical Center
Springfield, Illinois, 62781
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Southwest Regional Cancer Center
Austin, Texas, 78705
United States
South Carolina Oncology Associates
Columbia, South Carolina, 29201
United States
Interlakes Oncology/Hematology PC
Rochester, New York, 14623
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, 92708
United States
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
Additional Information:
Study ID Numbers: CDR0000068216; LILLY-B9E-MC-JHQG
Study Start Date: July 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006459
Other Recurrent Breast Cancer Studies:
1. Biological Therapy in Treating Women With Metastatic Breast Cancer
2. Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
3. Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
4. ICI 182780 in Treating Women With Metastatic Breast Cancer
5. Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Virginia Clinical Trials
Other Fairfax Clinical Trials
Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
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