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
- 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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.
after 6 course (6 months) of combination therapy
Paula Silverman, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|