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

NCT00499655 | Completed Phase 2 Results DMC

• 3 other identifiers: 06254NCI-2010-00353CDR0000549751
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Erlotinib hydrochloride and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Celecoxib may also stop the growth of lung cancer by blocking blood flow to the tumor. Giving erlotinib hydrochloride together with celecoxib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving erlotinib hydrochloride together with celecoxib works compared with erlotinib hydrochloride alone in treating patients with stage IIIB-IV non-small cell lung cancer.

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)

• Progression-free Survival

  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.

  Until disease progression, up to 5 years.

Secondary Outcomes (4)

• Number of Participants With Overall Response

  16 weeks post start of treatment

• Progression-free Survival - Elevated PGEM

  Until disease progression, up to 5 years.

• Progression-free Survival - EGRF

  Until disease progression, up to 5 years.

• Progression-free Survival - Low PGEM

  Until disease progression, up to 5 years.

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients receive oral erlotinib hydrochloride once daily and oral placebo twice daily on days 1-28.

Drug: erlotinib hydrochloride; Other: placebo; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: fluorescence in situ hybridization; Genetic: mutation analysis; Genetic: protein expression analysis; Genetic: gene expression analysis

Arm II

EXPERIMENTAL

Patients receive oral erlotinib hydrochloride once daily and oral celecoxib twice daily on days 1-28.

Drug: erlotinib hydrochloride; Drug: celecoxib; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: fluorescence in situ hybridization; Genetic: mutation analysis; Genetic: protein expression analysis; Genetic: gene expression analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

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

Arm I; Arm II

celecoxib DRUG

Given orally

Also known as: Celebrex, SC-58635, YM 177

Arm II

placebo OTHER

Given orally

Also known as: PLCB

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I; Arm II

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I; Arm II

fluorescence in situ hybridization GENETIC

Correlative studies

Also known as: fluorescence in situ hybridization (FISH)

Arm I; Arm II

mutation analysis GENETIC

Correlative studies

Arm I; Arm II

protein expression analysis GENETIC

Correlative studies

Arm I; Arm II

gene expression analysis GENETIC

Correlative studies

Arm I; Arm II

Eligibility Criteria

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

You may qualify if:

• Pathologically proven NSCLC, stage IIIB (defined as: with pleural effusion or recurrence after mediastinal radiation and chemotherapy) or IV
• Available tumor tissue for mutation screening
• Measurable stage IIIb or IV disease by RECIST guidelines
• ECOG performance status of 0 or 1
• Progressive disease despite \>= 1 prior chemotherapy regimens as standard of care or subject's refusal or inability to receive standard chemotherapy
• Normal renal function (defined as serum creatinine =\< 2mg/dl)
• Normal liver function (defined as serum total bilirubin =\< 1.5, and serum transaminases =\< 2.5X the upper limits of normal \[ULN\]); if liver metastases are present, serum transaminases \> 5X the ULN
• No evidence of coagulopathy (defined as PT and/or PTT =\< 1.5X ULN or platelets \>= 100,000)
• No evidence of leukopenia (defined as absolute neutrophil count \>= 1,500 mm\^3)
• Negative pregnancy test prior to initiation of treatment and adequate contraception throughout treatment

You may not qualify if:

• Cytotoxic chemotherapy agents within 4 weeks of initiating treatment; all toxicities must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior cancer treatment, except alopecia or any clinically insignificant effect, prior to study initiation
• Evidence of NYHA class III or greater cardiac disease, history of myocardial infarction, cerebral vascular accident, symptomatic ventricular arrhythmia, or symptomatic conduction abnormality
• Non-cytoxic therapy within 2 weeks of initiating treatment ; all toxicities must be recovered to baseline or NCI CTCAE v3.0 Grade 1 from all acute effects of prior cancer treatment, except alopecia or any clinically insignificant effect, prior to study initiation
• Prior radiotherapy to target lesions is not permitted unless completed more than 4 weeks prior to treatment within the study and that there has been documented progression at these sites (Radiotherapy to non-target lesions is permitted within 2 weeks of study entry provided all acute effects of the radiotherapy have resolved at least grade 1)
• Comorbid disease or a medical condition that would impair the ability of the subject to receive or comply with the study protocol
• Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer or cervical cancer in situ
• Hypersensitivity of erlotinib or celecoxib or to any of the excipients of these products
• Hypersensitivity to sulfonamides, aspirin or other NSAIDS
• Prior history of EGFR inhibitor for the treatment of cancer
• Previous history of gastrointestinal ulceration, bleeding or perforation
• Concurrent use of COX-2 inhibitors or other NSAIDS (For subjects on NSAIDS prior to study initiation, cessation of the drug for 72 hours prior to study entry is required)
• Chronic or concurrent use of steroids (topical steroids are acceptable if medically indicated)
• Subjects who require treatment with fluconazole or lithium
• Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
• Renal insufficiency (defined as serum creatinine \> 2 mg/dl)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• OSI Pharmaceuticals: collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Celecoxib; Immunohistochemistry; In Situ Hybridization, Fluorescence; Gene Expression Profiling

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; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization

Results Point of Contact

• Title: Karen L. Reckamp, M.D.
• Organization: City of Hope

kreckamp@coh.org

(626) 256-4673

Study Officials

• Karen Reckamp

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 11, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 29, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-02

Locations

US (2)