A Phase 1 interventional study of Etanercept and Docetaxel in Tumors, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 27 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Solid malignancy that has persisted or recurred following prior therapy or advanced solid malignancy for which docetaxel is considered an acceptable first line treatment option:
7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
Also known as: Enbrel
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.
Also known as: Taxotere
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.
Also known as: steriod, glucocorticoid
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
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center