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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
N/A
Not Enrolling
Both
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


OBJECTIVES:

- 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


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

Type of Study:

Interventional

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:

Yes

Principal Investigator

Elizabeth M. Gore, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical College of Wisconsin

Authority:

United States: Food and Drug Administration

Study ID:

RTOG-0213

NCT ID:

NCT00046839

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

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
St. John's Regional Health CenterSpringfield, Missouri  65804
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Trinity Cancer Care CenterMinot, North Dakota  58701
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Fox Chase Virtua Health Cancer Program - MarltonMarlton, New Jersey  08053
St. Joseph Hospital Community Cancer CenterBellingham, Washington  98225
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
Akron City Hospital at Summa Health SystemAkron, Ohio  44304
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Cancer Center at Paoli Memorial HospitalPaoli, Pennsylvania  19301
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
Albuquerque Regional Medical Center at Lovelace Sandia Health SystemAlbuquerque, New Mexico  87102
University of Wisconsin Cancer Center at Aspirus Wausau HospitalWausau, Wisconsin  54401
North Star Lodge Cancer CenterYakima, Washington  98902
Radiation Oncology CenterAlliance, Ohio  44601