Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors
NCT ID: NCT00201812
Last Updated: 2017-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2000-11-30
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Etanercept
7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Immunex Corporation
INDUSTRY
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Miguel Villalona
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University Medical Center
Columbus, Ohio, United States
Countries
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References
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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.
Related Links
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Jamesline
Other Identifiers
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OSU-0023
Identifier Type: -
Identifier Source: org_study_id