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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.
First Received: June 5, 2003   Last Updated: July 23, 2008   History of Changes
Sponsor: Rush University Medical Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062101
  Purpose

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.


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

Study Type: Interventional
Study Design: Treatment, Open Label
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

Resource links provided by NLM:


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

Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062101

Sponsors and Collaborators
Rush University Medical Center
Investigators
Study Chair: Philip D. Bonomi, MD Rush University Medical Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000304495, RUSH-LUNG-2001-1, NCI-5416
Study First Received: June 5, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00062101     History of Changes
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:
Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protein Kinase Inhibitors
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Erlotinib
Respiratory Tract Neoplasms
Celecoxib
Neoplasms by Histologic Type
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009