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

This study has been completed.
Sponsor:
Collaborator:
Immunex Corporation
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201812
First received: September 12, 2005
Last updated: December 18, 2012
Last verified: December 2012
  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: 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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept. [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 12, 2005
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dexamethasone acetate
TNFR-Fc fusion protein
Dexamethasone
Dexamethasone 21-phosphate
Glucocorticoids
Docetaxel
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on April 16, 2014