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| Name | Class |
|---|---|
| Immunex Corporation | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | 7 days prior to treatment with docetaxel. Administered twice weekly throughout the study. |
| |
| Docetaxel | Drug | 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. |
| |
| Dexamethasone | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept. | up to 4 years |
| 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. |
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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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Miguel Villalona | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16622259 | Result | Monk JP, Phillips G, Waite R, Kuhn J, Schaaf LJ, Otterson GA, Guttridge D, Rhoades C, Shah M, Criswell T, Caligiuri MA, Villalona-Calero MA. Assessment of tumor necrosis factor alpha blockade as an intervention to improve tolerability of dose-intensive chemotherapy in cancer patients. J Clin Oncol. 2006 Apr 20;24(12):1852-9. doi: 10.1200/JCO.2005.04.2838. |
| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D000077143 | Docetaxel |
| D003907 | Dexamethasone |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| up to 4 years |
| Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept. | up to 4 years |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |