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


Phase 1
18 Years
N/A
Not Enrolling
Both
Tumors

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

up to 4 years

Safety Issue:

Yes

Principal Investigator

Miguel Villalona

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-0023

NCT ID:

NCT00201812

Start Date:

November 2000

Completion Date:

May 2005

Related Keywords:

  • Tumors
  • Advanced Solid Tumors

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210