Spots Global Cancer Trial Database for Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
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Trial Identification
Brief Title: Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
Official Title: Phase III Study of Gemcitabine Plus Paclitaxel Versus Paclitaxel in Patients With Unresectable, Locally Recurrent or Metastatic Breast Cancer
Study ID: NCT00006459
Conditions
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: I. Compare overall survival of patients with unresectable, locally recurrent, or metastatic breast cancer treated with paclitaxel with or without gemcitabine. 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, Saint 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
Contact Details
Name: Furhan Yunus, MD, FACP
Affiliation: University of Tennessee
Role: STUDY_CHAIR
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