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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


Phase 1
21 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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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 UCLALos Angeles, California  90095-1781