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

NCT00201812 | Completed Phase 1 DMC

• 1 other identifier: OSU-0023
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumors

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept.

  up to 4 years

Secondary Outcomes (3)

• 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.

  up to 4 years

• Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept.

  up to 4 years

Interventions

Etanercept DRUG

7 days prior to treatment with docetaxel. Administered twice weekly throughout the study.

Also known as: Enbrel

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.

Also known as: Taxotere

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.

Also known as: steriod, glucocorticoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Immunex Corporation: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related 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 chemotherapy in cancer patients. J Clin Oncol. 2006 Apr 20;24(12):1852-9. doi: 10.1200/JCO.2005.04.2838.

  PMID: 16622259 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Neoplasms

Interventions

Etanercept; Docetaxel; Dexamethasone; Glucocorticoids

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Miguel Villalona

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2000
• Primary Completion: January 1, 2004
• Study Completion: May 1, 2005
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (1)