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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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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• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Celecoxib; Erlotinib Hydrochloride

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