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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00062101
First received: June 5, 2003
Last updated: June 5, 2013
Last verified: June 2013
  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. 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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Condition Intervention Phase
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: erlotinib hydrochloride
Drug: celecoxib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Outcome Measures:
  • Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.

  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.

  • Relationship between measures of treatment efficacy and EGFR and COX-2 levels [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2004
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
Drug: erlotinib hydrochloride
Given orally (PO)
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Drug: celecoxib
Given PO
Other Names:
  • Celebrex
  • SC-58635
Other: laboratory biomarker analysis
Correlative studies
Experimental: Group II (erlotinib hydrochloride)
Patients receive erlotinib as in group 1.
Drug: erlotinib hydrochloride
Given orally (PO)
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Principal Investigator: Philip Bonomi Rush University Medical Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00062101     History of Changes
Other Study ID Numbers: NCI-2012-02720, LUNG 2002-01, NCI-5416, CDR0000304495
Study First Received: June 5, 2003
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Celecoxib
Erlotinib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014