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

NCT00201812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-12-06

No results posted yet for this study

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

Interventions

DRUG

Etanercept

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

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.

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.

Sponsors & Collaborators

  • Immunex Corporation

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Miguel Villalona · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Primary Completion
2004-01-31
Completion
2005-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201812 on ClinicalTrials.gov