Completed

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

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What is being tested

erlotinib hydrochloride

+ celecoxib
+ laboratory biomarker analysis
Drug
Other
Who is being recruted

Recurrent Non-small Cell Lung Cancer

+ Stage IIIB Non-small Cell Lung Cancer
+ Stage IV Non-small Cell Lung Cancer
Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2003

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: October 10, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating former smokers with stage IIIB, stage IV, recurrent, or progressive non-small cell lung cancer. Celecoxib and erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PRIMARY OBJECTIVE: I. To estimate the clinical toxicity and tolerability of erlotinib combined with celecoxib in patients with advanced non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To estimate the tumor response rate of erlotinib combined with celecoxib in patients with advanced NSCLC. II. To estimate the dose of celecoxib that results in maximal induction of apoptosis, maximal inhibition of prostaglandin E2 (PGE2) in bronchoalveolar (BAL) fluid, and maximal inhibition of bronchial cell proliferation when combined with erlotinib. III. To estimate the effect of erlotinib and the combination of erlotinib and celecoxib on bronchial expression of COX-2. IV. To estimate the effect of erlotinib and the combination of erlotinib (and celecoxib on autophosphorylation of epidermal growth factor receptor (EGFR) in skin and endobronchial biopsies. V. To estimate the degree of correlation of autophosphorylation of EGFR in skin and endobronchial samples. TERTIARY OBJECTIVES: I. To estimate the effect of the combination of erlotinib and COX-2 inhibitor (celecoxib) on the frequency of fractional allelic loss (FAL) in endobronchial biopsies, metaplasia and dysplasia in endobronchial biopsies, and endobronchial proliferation. OUTLINE: This is an open-label, dose-escalation study of celecoxib. Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients are treated at the MTD. Patients are followed at 4 weeks.

Official TitlePhase I Study of Erlotinib and Celecoxib in Former Smokers With Advanced Non-Small Cell Lung Cancer 
Principal SponsorNational Cancer Institute (NCI)
Last updated: October 10, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
45 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Criteria

Criteria: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) meeting 1 of the following stage criteria: Stage IIIB with pleural effusion; Stage IV disease; recurrent or progressive disease after prior surgery, radiotherapy, and/or chemotherapy * If the sole prior treatment was in the adjuvant or neoadjuvant setting, tumor progression or recurrence must have occurred within 6 months after completion of prior treatment * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 10 g/dL * Hemostasis normal * Creatinine =\< 2.0 mg/dL * No significant cardiovascular disease * No New York Heart Association class III or IV cardiac disease * No uncontrolled dysrhythmia * No unstable angina * No myocardial infarction within the past 6 months * FEV1 \>= 1.0 liter OR 40% of predicted within the past 3 months * Oxygen saturation \>= 90% on room air * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study treatment * Willing to undergo bronchoscopy * No allergy to sulfonamides or hypersensitivity reaction to celecoxib * No other medical or psychological condition (e.g., acute psychosis) that would preclude study participation * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin) * At least 4 weeks since prior radiotherapy * Prior complete resection allowed provided there is histologic and cytologic documentation of disease recurrence * More than 3 months since prior chemopreventative agents (e.g., oltipraz, retinoids, or N-acetylcysteine \[NAC\]) * No prior erlotinib hydrochloride * No other prior EGFR antagonists * No concurrent medication known to interact with erlotinib hydrochloride or celecoxib, including the following: Fluconazole, Lithium, Furosemide, Angiotensin-converting enzyme inhibitors, Phenytoin, Carbamazepine, Rifampin, Barbiturates, Hypericum perforatum (St. John's wort) * No concurrent non-steroidal anti-inflammatory drugs * Concurrent aspirin of up to an average dose of 325 mg/day allowed * No aspirin treatment for 7 days prior to any bronchoscopic or skin biopsy * No other concurrent EGFR inhibitors or cyclo-oxygenase-2 (COX-2) inhibitors * Meets 1 of the following criteria: 1) Advanced NSCLC with at least stable disease after \>= 4 courses of platinum-containing chemotherapy 2) Relapsed or refractory disease after treatment with \>= 1 prior platinum-containing chemotherapy program, including adjuvant or neoadjuvant therapy for NSCLC * No untreated brain metastases * ECOG 0-1 * Former smoker, as indicated by the following: 1) At least a 30 pack-year smoking history 2) Smoking duration at least 10 years 3) At least 12 months of self-reported smoking cessation 4) Negative urine cotinine


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Duke University Medical CenterDurham, United StatesSee the location

CompletedOne Study Center