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

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
celecoxib
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (erlotinib hydrochloride, celecoxib)

Group II (erlotinib hydrochloride)

Arm Description

Patients receive oral erlotinib once daily and oral celecoxib twice daily.

Patients receive erlotinib as in group 1.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Overall survival
Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.
Relationship between measures of treatment efficacy and EGFR and COX-2 levels
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0

Full Information

First Posted
June 5, 2003
Last Updated
June 5, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062101
Brief Title
Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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. .
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (erlotinib hydrochloride, celecoxib)
Arm Type
Experimental
Arm Description
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
Arm Title
Group II (erlotinib hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive erlotinib as in group 1.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
Given orally (PO)
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex, SC-58635
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
From the start of treatment until disease progression/recurrence, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Time to progression
Description
Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.
Time Frame
Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years
Title
Overall survival
Description
Will be analyzed by calculating Kaplan Meier curves and estimating medians and 95% confidence intervals using the method of Brookmeyer and Crowley.
Time Frame
Up to 5 years
Title
Relationship between measures of treatment efficacy and EGFR and COX-2 levels
Time Frame
Up to 5 years
Title
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Bonomi
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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

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