To determine the safety and efficacy of the combination of Etanercept and Docetaxel in patients with advanced solid tumors for which there is no standard treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
Administered intervenously (IV) over 30 minutes through an infusion pump once a week (every 7 days). A cycle will comprise six weekly treatments followed by 2 weeks of rest.
Administered orally 8 mg 12 hours prior to docetaxel, immediately prior to docetaxel (two hours after etanercept), and 12 hours after docetaxel to complete a total of 3 doses (total dose 24 mg/week) on treatment weeks.
Ohio State University Medical Center
Columbus, Ohio, United States
Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept.
Time frame: up to 4 years
Characterize toxicities of weekly docetaxel when administered weekly to patients with solid malignancies to determine if co-administration of etanercept can result in higher tolerated doses of docetaxel.
Time frame: up to 4 years
Determine if weekly docetaxel administration is associated with increased expression of TNF and if inactivation of TNF by etanercept is associated with a decrease in the rate of moderate to severe asthenia.
Time frame: up to 4 years
Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept.
Time frame: up to 4 years
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