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CompletedPhase 1 / Phase 2NCT00046839
Official study title

Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer

Study summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcelecoxib and radiation therapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 17, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?44 U.S. locations

Locations may change over time.

Who runs it?Radiation Therapy Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Radiation Therapy Oncology Group
Interventions being studied
Drug: celecoxib; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→
Treatment approach
Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed non-small cell lung cancer
  • Inoperable stage IIB OR
  • Unresectable stage IIIA or IIIB
  • No evidence of hematogenous metastases PATIENT CHARACTERISTICS: Age
  • 18 and over Performance status
  • Zubrod 2 AND more than 5% weight loss over the past 3 months OR
  • Zubrod 0-1 AND less than 5% weight loss over the past 3 months and refuses chemotherapy or are medically unable to tolerate combined modality therapy Life expectancy
  • Not specified Hematopoietic
  • Not specified Hepatic
  • Bilirubin no greater than 2 times upper limit of normal
  • International Normalized Ratio (INR) no greater than 3.0 if taking warfarin Renal
  • Creatinine clearance at least 50 mL/min Other
  • No active gastrointestinal ulcers or bleeding within the past 3 months
  • No other malignancy within the past 3 years except nonmelanoma skin cancer
  • No known hypersensitivity to celecoxib
  • No prior allergic-type reactions to sulfonamides
  • No prior asthma, urticaria, or allergic-type reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy
  • Not specified Chemotherapy
  • No prior neoadjuvant chemotherapy
  • No concurrent chemotherapy Endocrine therapy
  • No concurrent corticosteroids Radiotherapy
  • No prior thoracic radiotherapy Surgery
  • No prior complete or subtotal tumor resection Other
  • No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme inhibitors
  • Concurrent aspirin (325 mg/day) for cardioprotection allowed

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Hospital Cancer CenterColorado Springs, Colorado
  • University of Florida Shands Cancer CenterGainesville, Florida
  • Baptist Cancer Institute - JacksonvilleJacksonville, Florida
  • University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida
  • Regional Radiation Oncology Center at RomeRome, Georgia
  • Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois
  • Indiana University Cancer CenterIndianapolis, Indiana
  • Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa
  • Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky
  • West Michigan Cancer CenterKalamazoo, Michigan
  • Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota
  • CCOP - Metro-MinnesotaSaint Louis Park, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 17, 2015. Always confirm current availability with the study team.

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