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

Alternate Title

Celecoxib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 21 and over NCI UCLA-0306083 NCT00072072

Objectives

Primary

1. Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer.
2. Determine the toxicity profile of this regimen in these patients.

Secondary

1. Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients.
2. Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IIIB or IV



• Measurable disease



• Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy



• No active CNS metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior corticosteroids
• No concurrent steroids (including chronic use)
  • Concurrent topical steroids allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 4 weeks since prior non-cytotoxic investigational agents
• More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
• No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC
• No prior epidermal growth factor receptor inhibitor for metastatic NSCLC
• No concurrent COX-2 inhibitors
• No concurrent NSAIDs
• No concurrent fluconazole or lithium

Patient Characteristics:

Age

• 21 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• Transaminases no greater than 2.5 times upper limit of normal (ULN)
• PT and/or PTT no greater than 1.5 times ULN

Renal

• Creatinine no greater than 2 mg/dL

Cardiovascular

• No New York Heart Association class III or IV cardiac disease
• No myocardial infarction within the past year
• No symptomatic ventricular arrhythmia
• No symptomatic conduction abnormality

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior gastrointestinal ulceration, bleeding, or perforation
• No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study
• No concurrent disease or medical condition that would preclude study treatment or compliance

Expected Enrollment

A total of 21-27 patients will be accrued for this study.

Outline

This is a nonrandomized, dose-escalation study of celecoxib.

Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion.

Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE₂ where no DLT occurs.

Patients are followed every 2 months.

Reckamp KL, Krysan K, Morrow JD, et al.: A phase I trial to determine the optimal biological dose of celecoxib when combined with erlotinib in advanced non-small cell lung cancer. Clin Cancer Res 12 (11 Pt 1): 3381-8, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Robert Figlin, MD, FACP, Principal investigator(Contact information may not be current)		Ph: 310-825-5268; 888-798-0719
Karen Reckamp, MD, Principal investigator		Ph: 310-825-5788; 888-798-0719

Registry Information
Official Title		A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer
Trial Start Date		2003-08-05
Registered in ClinicalTrials.gov		NCT00072072
Date Submitted to PDQ		2003-09-17
Information Last Verified		2006-01-25
NCI Grant/Contract Number		CA16042

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