Trial Outcomes & Findings for Erlotinib Hydrochloride With or Without Celecoxib in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NCT NCT00499655)

Last Updated: 2017-03-29

Results Overview

Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

107 participants

Primary outcome timeframe

Until disease progression, up to 5 years.

Results posted on

2017-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Erlotinib\Placebo Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Overall Study STARTED	53	54
Overall Study COMPLETED	53	54
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erlotinib Hydrochloride With or Without Celecoxib in Treating Patients With Stage IIIB-IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib\Placebo n=53 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=54 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Total n=107 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	63.5 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	53 Participants n=5 Participants	54 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: Until disease progression, up to 5 years.

Population: All patients receiving treatment.

Outcome measures

Outcome measures
Measure	Erlotinib\Placebo n=53 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=54 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Progression-free Survival	3.5 Months Interval 1.8 to 5.5	5.4 Months Interval 2.0 to 7.6

SECONDARY outcome

Timeframe: 16 weeks post start of treatment

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Erlotinib\Placebo n=53 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=54 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Number of Participants With Overall Response	17 Participants	12 Participants

SECONDARY outcome

Timeframe: Until disease progression, up to 5 years.

Population: Analysis on a subset of patients with elevated baseline urinary prostaglandin E metabolite (PGEM).

Outcome measures

Outcome measures
Measure	Erlotinib\Placebo n=30 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=30 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Progression-free Survival - Elevated PGEM	2.2 Months Interval 1.8 to 5.5	5.4 Months Interval 1.8 to 12.9

SECONDARY outcome

Timeframe: Until disease progression, up to 5 years.

Population: Analysis on a subset of patients with wild-type epidermal growth factor receptor (EGFR),

Outcome measures

Outcome measures
Measure	Erlotinib\Placebo n=27 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=31 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Progression-free Survival - EGRF	1.8 Months Interval 1.7 to 3.5	3.2 Months Interval 1.7 to 6.7

SECONDARY outcome

Timeframe: Until disease progression, up to 5 years.

Population: Analysis on a subset of patients with low baseline urinary prostaglandin E metabolite (PGEM).

Outcome measures

Outcome measures
Measure	Erlotinib\Placebo n=15 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=14 Participants Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Progression-free Survival - Low PGEM	5.4 Months Interval 1.7 to 7.2	6.8 Months Interval 1.7 to 9.0

Adverse Events

Erlotinib\Placebo

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Erlotinib\Celecoxib

Serious events: 2 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib\Placebo n=53 participants at risk Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=54 participants at risk Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Vascular disorders cerebrovascular ischemia	0.00% 0/53 • Adverse events occurred over a period of 6 years.	3.7% 2/54 • Number of events 2 • Adverse events occurred over a period of 6 years.
Vascular disorders cardiac ischemia	1.9% 1/53 • Number of events 1 • Adverse events occurred over a period of 6 years.	0.00% 0/54 • Adverse events occurred over a period of 6 years.

Other adverse events

Additional Information

Karen L. Reckamp, M.D.

City of Hope

Phone: (626) 256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Erlotinib\Placebo n=53 participants at risk Patients receive 150 mg of oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28. erlotinib hydrochloride: Given orally placebo: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies	Erlotinib\Celecoxib n=54 participants at risk Patients receive 150 mg of oral erlotinib hydrochloride once daily and 600 mg of oral celecoxib twice daily on days 1-28. erlotinib hydrochloride: Given orally celecoxib: Given orally laboratory biomarker analysis: Correlative studies immunohistochemistry staining method: Correlative studies fluorescence in situ hybridization: Correlative studies mutation analysis: Correlative studies protein expression analysis: Correlative studies gene expression analysis: Correlative studies
Skin and subcutaneous tissue disorders Rash	79.2% 42/53 • Number of events 42 • Adverse events occurred over a period of 6 years.	79.6% 43/54 • Number of events 43 • Adverse events occurred over a period of 6 years.
Gastrointestinal disorders Diarrhea	75.5% 40/53 • Number of events 40 • Adverse events occurred over a period of 6 years.	70.4% 38/54 • Number of events 38 • Adverse events occurred over a period of 6 years.
Skin and subcutaneous tissue disorders Dry skin	75.5% 40/53 • Number of events 40 • Adverse events occurred over a period of 6 years.	66.7% 36/54 • Number of events 36 • Adverse events occurred over a period of 6 years.
General disorders Fatigue	58.5% 31/53 • Number of events 31 • Adverse events occurred over a period of 6 years.	51.9% 28/54 • Number of events 28 • Adverse events occurred over a period of 6 years.
Investigations Elevated AST	50.9% 27/53 • Number of events 27 • Adverse events occurred over a period of 6 years.	46.3% 25/54 • Number of events 25 • Adverse events occurred over a period of 6 years.
Psychiatric disorders Anorexia	49.1% 26/53 • Number of events 26 • Adverse events occurred over a period of 6 years.	31.5% 17/54 • Number of events 17 • Adverse events occurred over a period of 6 years.
General disorders Nausea	32.1% 17/53 • Number of events 17 • Adverse events occurred over a period of 6 years.	25.9% 14/54 • Number of events 14 • Adverse events occurred over a period of 6 years.
Investigations Hypoalbuminemia	26.4% 14/53 • Number of events 14 • Adverse events occurred over a period of 6 years.	29.6% 16/54 • Number of events 16 • Adverse events occurred over a period of 6 years.
General disorders Stomatitis	22.6% 12/53 • Number of events 12 • Adverse events occurred over a period of 6 years.	27.8% 15/54 • Number of events 15 • Adverse events occurred over a period of 6 years.
Blood and lymphatic system disorders Anemia	15.1% 8/53 • Number of events 8 • Adverse events occurred over a period of 6 years.	33.3% 18/54 • Number of events 18 • Adverse events occurred over a period of 6 years.
Investigations Elevated creatinine	15.1% 8/53 • Number of events 8 • Adverse events occurred over a period of 6 years.	31.5% 17/54 • Number of events 17 • Adverse events occurred over a period of 6 years.
Investigations Elevated Alk Phos	20.8% 11/53 • Number of events 11 • Adverse events occurred over a period of 6 years.	22.2% 12/54 • Number of events 12 • Adverse events occurred over a period of 6 years.
Infections and infestations Paronychia	13.2% 7/53 • Number of events 7 • Adverse events occurred over a period of 6 years.	29.6% 16/54 • Number of events 16 • Adverse events occurred over a period of 6 years.
Blood and lymphatic system disorders Lymphopenia	7.5% 4/53 • Number of events 4 • Adverse events occurred over a period of 6 years.	18.5% 10/54 • Number of events 10 • Adverse events occurred over a period of 6 years.
Metabolism and nutrition disorders Weight Loss	17.0% 9/53 • Number of events 9 • Adverse events occurred over a period of 6 years.	9.3% 5/54 • Number of events 5 • Adverse events occurred over a period of 6 years.
General disorders Vomiting	13.2% 7/53 • Number of events 7 • Adverse events occurred over a period of 6 years.	7.4% 4/54 • Number of events 4 • Adverse events occurred over a period of 6 years.
Investigations Elevated bilirubin	11.3% 6/53 • Number of events 6 • Adverse events occurred over a period of 6 years.	7.4% 4/54 • Number of events 4 • Adverse events occurred over a period of 6 years.