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Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
This study has been completed.
Study NCT00062101   Information provided by National Cancer Institute (NCI)
First Received: June 5, 2003   Last Updated: July 23, 2008   History of Changes

June 5, 2003
July 23, 2008
 
January 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00062101 on ClinicalTrials.gov Archive Site
 
 
 
Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
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.

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.

Phase II
Interventional
Treatment, Open Label
Lung Cancer
  • Drug: celecoxib
  • Drug: erlotinib hydrochloride
 
Fidler MJ, Argiris A, Patel JD, Johnson DH, Sandler A, Villaflor VM, Coon J 4th, Buckingham L, Kaiser K, Basu S, Bonomi P. 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. 2008 Apr 1;14(7):2088-94.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00062101
 
CDR0000304495, RUSH-LUNG-2001-1, NCI-5416
Rush University Medical Center
National Cancer Institute (NCI)
Study Chair: Philip D. Bonomi, MD Rush University Medical Center
National Cancer Institute (NCI)
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP