Know Cancer

forgot password

A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [National Screening Committee# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors

Phase 1/Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [National Screening Committee# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors


- Determine the maximum tolerated dose and the recommended phase II dose of concurrent
celecoxib and limited-field radiotherapy in intermediate-prognosis patients with
locally advanced non-small cell lung cancer.

- Determine the efficacy and toxicity of this regimen in these patients.

- Determine how the predictors of mortality in the general population (i.e., comorbid
conditions, functional status, quality of life, and psychological status) influence
prognosis, toxicity, and outcomes of therapy in patients treated with this regimen.

- Correlate circulating levels of vascular endothelial growth factor (VEGF), basic
fibroblast growth factor (bFGF), and interleukin-8 (IL8) with survival in patients
treated with this regimen.

- Correlate circulating levels of interleukin-1 (IL1), interleukin-6 (IL6), and
transforming growth factor-beta (TGFB) with pulmonary toxicity in patients treated with
this regimen.

OUTLINE: This is a phase I dose-escalation study of celecoxib followed by a phase II,
multicenter study.

- Phase I: Patients receive oral celecoxib twice daily. Beginning on day 6, patients
undergo thoracic radiotherapy 5 days a week for 3-6.5 weeks . Patients continue to
receive celecoxib for up to 2 years in the absence of disease progression or
unacceptable toxicity.

- Phase II: If fewer than 3 of the first 6 patients experience dose-limiting toxicity,
then the dose of celecoxib is escalated for all patients in the study, including those
in the first cohort.

Quality of life is assessed at baseline and at 3, 6, and 12 months after start of therapy.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 6-12 patients will be accrued for the phase I portion of this
study and a total of 116 patients will be accrued for the phase II portion of this study
within 25 months.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer

- Inoperable stage IIB OR

- Unresectable stage IIIA or IIIB

- No evidence of hematogenous metastases



- 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


- Not specified


- Bilirubin no greater than 2 times upper limit of normal

- International Normalized Ratio (INR) no greater than 3.0 if taking warfarin


- Creatinine clearance at least 50 mL/min


- 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


Biologic therapy

- Not specified


- No prior neoadjuvant chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- No concurrent corticosteroids


- No prior thoracic radiotherapy


- No prior complete or subtotal tumor resection


- No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme

- Concurrent aspirin (325 mg/day) for cardioprotection allowed

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity (Phase I)

Outcome Time Frame:

Start of treatment to 90 days

Safety Issue:


Principal Investigator

Elizabeth M. Gore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical College of Wisconsin


United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Memorial Hospital Cancer Center Colorado Springs, Colorado  80909
Mercy Hospital Cancer Center - Scranton Scranton, Pennsylvania  18501
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Greenville Greenville, South Carolina  29615
Dixie Regional Medical Center Saint George, Utah  84770
LDS Hospital Salt Lake City, Utah  84143
Community Memorial Hospital Menomonee Falls, Wisconsin  53051
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Monmouth Medical Center Long Branch, New Jersey  07740-6395
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
St. John's Regional Health Center Springfield, Missouri  65804
Regional Radiation Oncology Center at Rome Rome, Georgia  30165
Trinity Cancer Care Center Minot, North Dakota  58701
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist Cancer Institute - Jacksonville Jacksonville, Florida  32207
Fox Chase Virtua Health Cancer Program - Marlton Marlton, New Jersey  08053
St. Joseph Hospital Community Cancer Center Bellingham, Washington  98225
Ingalls Cancer Care Center at Ingalls Memorial Hospital Harvey, Illinois  60426
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Park Nicollet Clinic St. Louis Park, Minnesota  55416
Wendt Regional Cancer Center at Finley Hospital Dubuque, Iowa  52001
Akron City Hospital at Summa Health System Akron, Ohio  44304
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem, Ohio  44460
Cancer Treatment Center Wooster, Ohio  44691
Cancer Center at Paoli Memorial Hospital Paoli, Pennsylvania  19301
All Saints Cancer Center at All Saints Healthcare Racine, Wisconsin  53405
Albuquerque Regional Medical Center at Lovelace Sandia Health System Albuquerque, New Mexico  87102
University of Wisconsin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
North Star Lodge Cancer Center Yakima, Washington  98902
Radiation Oncology Center Alliance, Ohio  44601