Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	RUSH-LUNG-2001-1 NCI-5416, NCT00062101, 5416

Objectives

1. 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.
2. Determine the time to progression in patients treated with this regimen.
3. Determine the survival duration of patients treated with this regimen.
4. Determine the toxicity of this regimen in these patients.
5. 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.

Entry Criteria

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

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

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/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Fidler MJ, Argiris A, Patel JD, et al.: The potential predictive value of cyclooxygenase-2 expression and increased risk of gastrointestinal hemorrhage in advanced non-small cell lung cancer patients treated with erlotinib and celecoxib. Clin Cancer Res 14 (7): 2088-94, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Rush Cancer Institute at Rush University Medical Center

Philip Bonomi, MD, Protocol chair		Ph: 312-942-8312 Email: Philip_Bonomi@rsh.net

Registry Information
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
Trial Completion Date		2008-01-14
Registered in ClinicalTrials.gov		NCT00062101
Date Submitted to PDQ		2003-04-25
Information Last Verified		2008-07-22

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