Anti-inhibitor Coagulant Complex |
Autoplex T; FEIBA VH Immuno |
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.
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
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: 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
- 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
Location Information
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
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
Resources
- Anti-inhibitor Coagulant Complex (Drug Digest)
- Autoplex T (Drug Digest)

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