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

This study is ongoing, but not recruiting participants.

Sponsored by:	Ohio State University Comprehensive Cancer Center
Information provided by:	Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00201812

Purpose

To determine the safety and efficacy of the combination of Etanerept and Docetaxel in patients with advanced solid tumors for which there is no standard treatment.

Condition	Intervention	Phase
Tumors	Drug: Etanercept Drug: Docetaxel	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors

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

Estimated Enrollment:	27
Study Start Date:	November 2000
Estimated Study Completion Date:	January 2004

Eligibility

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
ECOG Performance Status of 0-2
Must have adequate organ function
Neuropathy must be <=Grade 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201812

Locations

United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

Investigators

Principal Investigator:

Miguel Villalona

Ohio State University

More Information

Study ID Numbers:	OSU-0023
Study First Received:	September 12, 2005
Last Updated:	December 26, 2006
ClinicalTrials.gov Identifier:	NCT00201812
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009