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

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

Lung Cancer

Treatments

Drug: celecoxib

Drug: erlotinib hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00072072

CDR0000335434

UCLA-0306083

Details and patient eligibility

About

RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining celecoxib with erlotinib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

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

Secondary

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

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 PGE_2 where no DLT occurs.

Patients are followed every 2 months.

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

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

PATIENT CHARACTERISTICS:

Age

21 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

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

PRIOR CONCURRENT THERAPY:

Biologic therapy