Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
NCT ID: NCT00006459
Last Updated: 2012-06-07
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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COMPLETED
PHASE3
INTERVENTIONAL
2000-07-31
2005-10-31
Brief Summary
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PURPOSE: Randomized phase III trial to study the effectiveness of paclitaxel with or without gemcitabine in treating women who have advanced breast cancer.
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Detailed Description
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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
National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not update the record when the trial completed. In June 2012, NCI transferred the trial to Lilly's clinicaltrials.gov account and Lilly updated the record with the trial completion date. This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 (FDAAA).
Conditions
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Study Design
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TREATMENT
Interventions
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gemcitabine hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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Furhan Yunus, MD, FACP
Role: STUDY_CHAIR
University of Tennessee
Locations
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Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
Little Rock Hematology-Oncology Associates
Little Rock, Arkansas, United States
Pacific Coast Hematology/Oncology Medical Group
Fountain Valley, California, United States
Office of Alex J.P. Makalinao
Los Angeles, California, United States
Hematology/Oncology Group
Santa Rosa, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Danbury Internal Medicine
Danbury, Connecticut, United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, United States
Mercy Hospital
Miami, Florida, United States
Mountain States Tumor Institute
Boise, Idaho, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Indiana Community Cancer Care, Inc.
Indianapolis, Indiana, United States
Cancer Health Associates
Michigan City, Indiana, United States
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
APN-IMPATH Research Corporation
Fort Lee, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
HemOnCare, P.C.
Brooklyn, New York, United States
Interlakes Oncology/Hematology PC
Rochester, New York, United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, United States
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Office Of C. Michael Jones
Germantown, Tennessee, United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, United States
University of Tennessee, Memphis
Memphis, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Southwest Regional Cancer Center
Austin, Texas, United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, United States
Northern Virginia Oncology Group, P.C.
Fairfax, Virginia, United States
Countries
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References
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Smyth EN, Shen W, Bowman L, Peterson P, John W, Melemed A, Liepa AM. Patient-reported pain and other quality of life domains as prognostic factors for survival in a phase III clinical trial of patients with advanced breast cancer. Health Qual Life Outcomes. 2016 Mar 25;14:52. doi: 10.1186/s12955-016-0449-z.
Other Identifiers
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LILLY-B9E-MC-JHQG
Identifier Type: -
Identifier Source: secondary_id
CDR0000068216
Identifier Type: -
Identifier Source: secondary_id
2017
Identifier Type: -
Identifier Source: org_study_id
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