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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
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



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