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

Stage IV Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062101
• Other study ID #: NCI-2012-02720
• Secondary ID: LUNG 2002-01NCI-
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2003
• Last updated: June 5, 2013
• Start date: January 2004

Study information

• Verified date: June 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• erlotinib hydrochloride
Given orally (PO)
• celecoxib
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)		From the start of treatment until disease progression/recurrence, assessed up to 5 years	No
Secondary	Time to progression	Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.	Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years	No
Secondary	Overall survival	Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.	Up to 5 years	No
Secondary	Relationship between measures of treatment efficacy and EGFR and COX-2 levels		Up to 5 years	No
Secondary	Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0		Up to 5 years	Yes