Official Title: “A Phase II Study Of OSI 774 (IND Number 63383) In Combination With Celecoxib (Celebrex, Pharmacia) As Second-Line Therapy In Advanced Non-Small Cell Lung Cancer”

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

PURPOSE: This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: January 2008

OBJECTIVES: - Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy. - Determine the time to progression in patients treated with this regimen. - Determine the survival duration of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response, time to progression, and survival in patients treated with this regimen.

OUTLINE: Patients are assigned to 1 of 2 treatment groups. - Group 1: Patients receive oral erlotinib once daily and oral celecoxib twice daily. - Group 2: Patients receive erlotinib as in group 1. Treatment in both groups continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 10 months.

Intervention(s) in this Clinical Trial

• Drug: celecoxib
• Drug: erlotinib hydrochloride

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer
• Stage IIIB (malignant pleural effusion only) or IV
• Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based)
• At least 1 unidimensionally measurable lesion*
• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• NOTE: *The sole measurable lesion must not be in a previously irradiated field
• Must have tissue specimen available for assays
• No brain metastases

PATIENT CHARACTERISTICS:

• Age
• 18 and over
• Performance status
• ECOG 0-2 OR
• Karnofsky 60-100%
• Life expectancy
• More than 3 months
• Hematopoietic
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hepatic
• Bilirubin normal
• AST/ALT no greater than 2.5 times upper normal limit (ULN)
• Renal
• Creatinine normal OR
• Creatinine clearance at least 60 mL/min
• Cardiovascular
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Ophthalmic
• No prior abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
• No congenital abnormality (e.g., Fuch's dystrophy)
• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
• No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
• Gastrointestinal
• Able to ingest oral medication
• No requirement for IV alimentation
• No history of peptic ulcer disease
• No active gastrointestinal ulcers
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other concurrent uncontrolled illness
• No ongoing or active infection
• No significant traumatic injury within the past 21 days
• No psychiatric illness or social situation that would preclude study compliance
• No prior allergic reactions to sulfonamides, aspirin, and other nonsteroidal anti-inflammatory drugs

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• No prior monoclonal antibodies to epidermal growth factor receptor (EGFR)
• Chemotherapy
• See Disease Characteristics
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No concurrent chemotherapy
• Endocrine therapy
• No concurrent glucocorticoids
• Radiotherapy
• See Disease Characteristics
• More than 4 weeks since prior radiotherapy and recovered
• Surgery
• More than 21 days since prior major surgery
• No prior surgery affecting absorption
• Other
• No prior EGFR-specific tyrosine kinases
• No concurrent anticonvulsants
• No other concurrent investigational agents
• No concurrent antiretroviral therapy for HIV-positive patients
• No concurrent antacids
• No concurrent administration of any of the following drugs:
• Amiodarone
• Chloramphenicol
• Cimetidine
• Fluvoxamine
• Omeprazole
• Zafirlukast
• Clopidogrel
• Cotrimoxazole
• Disulfiram
• Fluconazole
• Fluoxetine
• Fluvastatin
• Fluvoxamine
• Isoniazid
• Itraconazole
• Ketoconazole
• Leflunomide
• Metronidazole
• Modafinil
• Paroxetine
• Phenylbutazone
• Sertraline
• Ticlopidine
• Valproic acid

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Rush University Medical Center

Overall Clinical Trial Officials and Contacts

Philip D. Bonomi, MD Study Chair Rush University Medical Center  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00062101

Study ID Number: CDR0000304495

ClinicalTrials.gov Identifier: NCT00062101

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database