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OpenTrials
Completed

NCT Number: NCT00201812

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

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.

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Key information

Conditions

Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

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

Other names: 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.

Other names: 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.

Other names: steriod, glucocorticoid

Primary outcomes

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

    Time frame: up to 4 years

Secondary outcomes

  1. 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.

    Time frame: up to 4 years

  2. 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.

    Time frame: up to 4 years

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

    Time frame: up to 4 years

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Immunex Corporation

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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