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COMPLETED Phase 3

Docetaxel With or Without Infliximab in Treating Weight Loss, Loss of Appetite, and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer (Infliximab Treatment Discontinued Effective 10/05/05)

NCT00040885 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Infliximab may improve cancer-related weight loss, lack of appetite, and fatigue. It is not yet known whether docetaxel is more effective with or without infliximab in preventing weight loss and fatigue in patients with advanced cancer. (Infliximab treatment discontinued effective 10/05/05) PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel with or without infliximab in preventing weight loss, loss of appetite, and fatigue in patients who have unresectable non-small cell lung cancer. (Infliximab treatment discontinued effective 10/05/05)

Interventions

  • OTHER placebo
  • DRUG docetaxel
  • BIOLOGICAL infliximab

Study Locations (20)

Colorado

  • Aurora Presbyterian Hospital — Aurora
  • Boulder Community Hospital — Boulder
  • Penrose Cancer Center at Penrose Hospital — Colorado Springs
  • Porter Adventist Hospital — Denver
  • Presbyterian - St. Luke's Medical Center — Denver
  • St. Joseph Hospital — Denver
  • Rose Medical Center — Denver
  • CCOP - Colorado Cancer Research Program, Incorporated — Denver
  • Swedish Medical Center — Englewood
  • Sky Ridge Medical Center — Lone Tree
  • Hope Cancer Care Center at Longmont United Hospital — Longmont
  • St. Mary-Corwin Regional Medical Center — Pueblo
  • North Suburban Medical Center — Thorton

Illinois

  • Rush-Copley Cancer Care Center — Aurora
  • St. Joseph Medical Center — Bloomington
  • Graham Hospital — Canton
  • Memorial Hospital — Carthage
  • Eureka Community Hospital — Eureka

Arizona

  • CCOP - Mayo Clinic Scottsdale Oncology Program — Scottsdale

Florida

  • Mayo Clinic - Jacksonville — Jacksonville

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2002-10
Est. Completion 2008-10
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00040885

The ClinicalTrials.gov registry entry for NCT00040885 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 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which placebo 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: NCT00040885 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Colorado, Illinois, 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 NCT00040885 about?

NCT00040885 is a clinical study titled "Docetaxel With or Without Infliximab in Treating Weight Loss, Loss of Appetite, and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer (Infliximab Treatment Discontinued Effective 10/05/05)". RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Infliximab may improve cancer-related weight loss, lack of appetite, and fatigue. It is not yet known whether docetaxel is more effective with or without in...

What is the current status of trial NCT00040885?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2002-10. Estimated completion is 2008-10.

What conditions does trial NCT00040885 study?

This clinical trial studies the following conditions: Lung Cancer, Fatigue, Cachexia, Anorexia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00040885?

The interventions under investigation include: placebo (OTHER), docetaxel (DRUG), infliximab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00040885?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00040885 being conducted?

This trial has 20 study locations across Arizona, Colorado, Florida, Illinois. 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