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NCT00346801 · ClinicalTrials.gov registry record · Phase 1

CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)

A Phase 1 study of Lung Cancer, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT00346801: Completed Phase 1 study of Lung Cancer, sponsored by M.D. Anderson Cancer Center.

NCT00346801 is a Phase 1 study of Lung Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 20 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00346801, a Phase 1 study of Lung Cancer, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

Primary Objectives: * To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC. * To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy. * To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.

Conditions Studied

Interventions

  • DRUG Cisplatin
  • DRUG Celecoxib
  • DRUG CPT-11
  • RADIATION Concurrent Thoracic Radiation Therapy

Study Locations (1)

Texas

  • UT MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2003-09
Phase Phase 1

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00346801

The ClinicalTrials.gov registry entry for NCT00346801 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (98% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.

NCT00346801 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00346801 about?

NCT00346801 is a clinical study titled "CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)". Primary Objectives: * To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC. * To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC t...

What is the current status of trial NCT00346801?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2003-09.

What conditions does trial NCT00346801 study?

This clinical trial studies the following conditions: Lung Cancer.

What interventions are being tested in trial NCT00346801?

The interventions under investigation include: Cisplatin (DRUG), Celecoxib (DRUG), CPT-11 (DRUG), Concurrent Thoracic Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT00346801?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00346801 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.