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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tumors

Intervention / Treatment
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* Drug: Etanercept
* Drug: Docetaxel
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept. |  | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumors