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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201812
First Posted: September 20, 2005
Last Update Posted: December 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center
  Purpose
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.

Condition Intervention Phase
Tumors Drug: Etanercept Drug: Docetaxel Drug: Dexamethasone Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Miguel Villalona, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept. [ Time Frame: up to 4 years ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 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. [ Time Frame: up to 4 years ]
  • Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept. [ Time Frame: up to 4 years ]

Enrollment: 27
Study Start Date: November 2000
Study Completion Date: May 2005
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Etanercept
    7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.
    Other Name: Enbrel
    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.
    Other Name: Taxotere
    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.
    Other Names:
    • steriod
    • glucocorticoid
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201812


Locations
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Immunex Corporation
Investigators
Principal Investigator: Miguel Villalona Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Miguel Villalona, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201812     History of Changes
Other Study ID Numbers: OSU-0023
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by Miguel Villalona, Ohio State University Comprehensive Cancer Center:
Advanced Solid Tumors

Additional relevant MeSH terms:
Dexamethasone
Etanercept
Glucocorticoids
Docetaxel
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors