Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Determine the efficacy and toxicity of this regimen in these patients.
3. 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.
4. Correlate circulating levels of vascular endothelial growth factor, basic fibroblast growth factor, and interleukin-8 with survival in patients treated with this regimen.
5. Correlate circulating levels of interleukin-1, interleukin-6, and tranforming growth factor-beta with pulmonary toxicity in patients treated with this regimen.

Entry 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

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

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
• 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

Expected Enrollment

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.

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.

Gore E, Bae K, Langer C, et al.: Phase I/II trial of a COX-2 inhibitor with limited field radiation for intermediate prognosis patients who have locally advanced non-small-cell lung cancer: radiation therapy oncology group 0213. Clin Lung Cancer 12 (2): 125-30, 2011.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Elizabeth Gore, MD, Protocol chair		Ph: 414-805-4369 Email: bethgore@mcw.edu

Registry Information
Official Title		A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [NSC# 719627] with Limited Field Radiation for Intermediate Prognosis Patients with Locally Advanced Non-Small Cell Lung Cancer, with Analysis of Prognostic Factors
Trial Start Date		2002-07-30
Trial Completion Date		2011-09-15
Registered in ClinicalTrials.gov		NCT00046839
Date Submitted to PDQ		2002-06-04
Information Last Verified		2005-06-15
NCI Grant/Contract Number		CA21661

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