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

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072072

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: celecoxib Drug: erlotinib hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Celecoxib Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2003

Detailed 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072072

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Robert A. Figlin, MD, FACP	Jonsson Comprehensive Cancer Center
Principal Investigator:	Karen Rickard	Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Reckamp KL, Krysan K, Morrow JD, Milne GL, Newman RA, Tucker C, Elashoff RM, Dubinett SM, Figlin RA. 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. 2006 Jun 1;12(11 Pt 1):3381-8.

ClinicalTrials.gov Identifier:	NCT00072072 History of Changes
Other Study ID Numbers:	CDR0000335434, UCLA-0306083
Study First Received:	November 4, 2003
Last Updated:	March 11, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Celecoxib
Erlotinib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012