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

NCT00088959 | Completed Phase 1

• 8 other identifiers: NCI-2009-008864939-04-6R2DUMC-4939-03-6R0VAMC-DURHAM-00813DUMC-GCRC-911CDR0000377689DUMC-4939-04-6R2U01CA096123
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Clinical tolerable dose of celecoxib as measured by NCI CTCAE v3.0

  4 weeks

Study Arms (1)

Treatment (erlotinib hydrochloride, celecoxib)

EXPERIMENTAL

Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochloride; Drug: celecoxib; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

Treatment (erlotinib hydrochloride, celecoxib)

celecoxib DRUG

Given orally

Also known as: Celebrex, SC-58635

Treatment (erlotinib hydrochloride, celecoxib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (erlotinib hydrochloride, celecoxib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Celecoxib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael Kelley

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: December 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2010
• Last Updated: October 10, 2014

Record last verified: 2013-04

Locations

US (1)