Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Tumors
- Registration Number
- NCT00201812
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
-
Must have pathologically or cytologically confirmed advanced solid malignancy for which there is no standard treatment exists.
-
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:
- Non-Small Cell Lung
- Breast
- Head and Neck
- Esophageal
- Stomach
- Ovarian carcinomas
-
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
-
Life expectancy of at least 12 weeks.
-
Must have adequate organ function
-
Peripheral Neuropathy must be less than Grade 2
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept. up to 4 years
- Secondary Outcome Measures
Name Time Method 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. 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. up to 4 years Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept. up to 4 years
Trial Locations
- Locations (1)
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States