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
21 Years
N/A
Both
Lung Cancer
Trial Information
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
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.
Inclusion 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
- 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Robert A. Figlin, MD, FACP
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000335434
NCT ID:
NCT00072072
Start Date:
August 2003
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
