NCT00201812

Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tumors

Interventions

Type	Name	Description
DRUG	Etanercept	7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
DRUG	Docetaxel	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.
DRUG	Dexamethasone	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.

Timeline

• Start date: 2000-11-01
• Primary completion: 2004-01-01
• Completion: 2005-05-01
• First posted: 2005-09-20
• Last updated: 2017-12-06

Locations

1 site across 1 country: United States