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A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent breast cancer.
OBJECTIVES: * Determine the antitumor effects of erlotinib and docetaxel, in terms of objective response, stabilization of disease, and progression-free survival, in patients with stage IV or recurrent breast cancer. * Determine time to tumor progression in patients treated with this regimen. * Compare time to tumor progression in patients who achieve disease stabilization or response after treatment with this regimen and continue to receive erlotinib versus patients who do not receive additional erlotinib. OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients achieving maximal tumor response or stabilization of disease after 6 courses may continue to receive erlotinib alone until disease progression. Patients are followed for survival. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
December 1, 2002
Primary Completion Date
April 1, 2010
Completion Date
November 1, 2012
Last Updated
February 17, 2016
39
ACTUAL participants
docetaxel
DRUG
erlotinib hydrochloride
DRUG
Lead Sponsor
Paula Silverman, MD
Collaborators
NCT04704661
NCT05372640
Data Source & Attribution
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