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

Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201812
• Other study ID #: OSU-0023
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: December 4, 2017
• Start date: November 2000
• Est. completion date: May 2005

Study information

• Verified date: December 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2005
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Immunex Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ch — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept.		up to 4 years
Secondary	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
Secondary	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
Secondary	Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept.		up to 4 years

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