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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

Phase 2
18 Years
Not Enrolling
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

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


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.


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

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 10

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

- No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

From the start of treatment until disease progression/recurrence, assessed up to 5 years

Safety Issue:


Principal Investigator

Philip Bonomi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rush University Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Rush University Medical Center Chicago, Illinois  60612-3824