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COMPLETED Phase 3

A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients

NCT00085826 · View on ClinicalTrials.gov ↗

Study Summary

Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone. This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere. This study has been completed and a publication is pending.

Conditions Studied

Interventions

  • DRUG Exisulind

Study Locations (20)

Colorado

  • Rocky Mountain Cancer Center — Boulder
  • Rocky Mountain Cancer Centers — Colorado Springs
  • RMCC — Denver
  • 12. Rocky Mountain Cancer Centers-Englewood — Englewood
  • Rocky Mountain Cancer Centers — Englewood
  • Rocky Mountain Cancer Centers — Fort Collins
  • Rocky Mountain Cancer Centers — Littleton
  • Rocky Mountain Cancer Centers — Thornton

California

  • Pacific Coast Hematology/Oncology Medical Group, Inc. — Fountain Valley
  • California Cancer Care, Inc. — Greenbrae
  • Scripps Cancer Center — San Diego
  • Sharp Clinical Oncology Research — San Diego
  • Redwood Regional Medical Group — Santa Rosa

Arizona

  • Northern Arizona Hematology and Oncology Associates — Flagstaff
  • Hematology & Oncology Associates — Phoenix
  • Northern Arizona Hematology & Oncology Associates — Sedona
  • Arizona Clinical Research Center — Tucson

Alabama

  • Birmingham Hematology Oncology Associates — Birmingham
  • Birmingham Hematology and Oncology Associates, LLC — Birmingham

Arkansas

  • Arkansas Oncology Associates, PA — Little Rock

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2001-04
Est. Completion 2004-12
Phase Phase 3

Sponsor

Astellas Pharma

51 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00085826

The ClinicalTrials.gov registry entry for NCT00085826 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which Exisulind is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00085826 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Colorado, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00085826 about?

NCT00085826 is a clinical study titled "A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients". Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged surviva...

What is the current status of trial NCT00085826?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2001-04. Estimated completion is 2004-12.

What conditions does trial NCT00085826 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00085826?

The interventions under investigation include: Exisulind (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00085826?

This trial is sponsored by Astellas Pharma, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00085826 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial