Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: celecoxib (Drug); erlotinib hydrochloride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Rush University Medical Center Official(s) and/or principal investigator(s):
Philip D. Bonomi, MD, Study Chair, Affiliation: Rush University Medical Center
Summary
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.
Clinical Details
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
Study design: Treatment, Open Label
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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 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
Locations and Contacts
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: May 23, 2008
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