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

NCT ID: NCT00062101

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

Brief Summary

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. 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.

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Detailed Description

PRIMARY OBJECTIVES:

I. 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.

SECONDARY OBJECTIVES:

I. Determine the time to progression in patients treated with this regimen. II. Determine the survival duration of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. 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.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I (erlotinib hydrochloride, celecoxib)

Patients receive oral erlotinib once daily and oral celecoxib twice daily.

Group Type: EXPERIMENTAL

erlotinib hydrochloride

Intervention Type: DRUG

Given orally (PO)

celecoxib

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Group II (erlotinib hydrochloride)

Patients receive erlotinib as in group 1.

Group Type: EXPERIMENTAL

erlotinib hydrochloride

Intervention Type: DRUG

Given orally (PO)

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

erlotinib hydrochloride

Given orally (PO)

Intervention Type: DRUG

celecoxib

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CP-358,774; erlotinib; OSI-774; Celebrex; SC-58635

Eligibility Criteria

Inclusion Criteria

• 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
• Must have tissue specimen available for assays
• No brain metastases
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin normal
• AST/ALT no greater than 2.5 times upper normal limit (ULN)
• Creatinine normal
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• 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)
• Able to ingest oral medication
• No requirement for IV alimentation
• No history of peptic ulcer disease
• No active gastrointestinal ulcers
• 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
• No prior monoclonal antibodies to epidermal growth factor receptor (EGFR)
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No concurrent chemotherapy
• No concurrent glucocorticoids
• More than 4 weeks since prior radiotherapy and recovered
• More than 21 days since prior major surgery
• No prior surgery affecting absorption
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Bonomi

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

LUNG 2002-01

Identifier Type: -

Identifier Source: secondary_id

NCI-5416

Identifier Type: -

Identifier Source: secondary_id

CDR0000304495

Identifier Type: -

Identifier Source: secondary_id

NCI-2012-02720

Identifier Type: -

Identifier Source: org_study_id