Tumors
Conditions
Keywords
Advanced Solid Tumors
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.
Interventions
DRUGDexamethasone
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.
DRUGEtanercept
7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
DRUGDocetaxel
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.
Sponsors
Immunex Corporation
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept. | up to 4 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed