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

The Ohio State University

Status and phase: Completed; Phase 1

Conditions: Tumors

Treatments: Drug: Docetaxel; Drug: Dexamethasone; Drug: Etanercept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00201812

OSU-0023

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)