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


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Celecoxib

Celebrex 




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

This study is no longer recruiting patients.

Sponsors and Collaborators: Rush Cancer Institute at Rush University Medical Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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: Phase II trial to study the effectiveness of combining erlotinib with celecoxib in treating patients who have recurrent stage IIIB or stage IV non-small cell lung cancer.

Condition Treatment or Intervention Phase
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
 Drug: celecoxib
 Drug: erlotinib
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: enzyme inhibitor therapy
 Procedure: growth factor antagonist therapy
 Procedure: protein tyrosine kinase inhibitor therapy
Phase II

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Erlotinib and Celecoxib as Second-Line Therapy in Patients With Stage IIIB or IV Recurrent Non-Small Cell Lung Cancer

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized study.

Patients receive oral erlotinib once daily and oral celecoxib twice daily. Treatment 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 above,  Genders Eligible for Study:  Both

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 and only 1 prior chemotherapy regimen (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 active 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

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

Location Information

Study chairs or principal investigators

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

More Information

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

Study ID Numbers:  CDR0000304495; RUSH-LUNG-2001-1; NCI-5416
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  June 5, 2003
ClinicalTrials.gov Identifier:  NCT00062101
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 5, 2009



Page Updated: September 6, 2005
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