Laboratory Test in Predicting Response to Erlotinib in Patients With Relapsed Metastatic or Unresectable Non-Small Cell Lung Cancer That Did Not Respond to Previous Treatment

NCT00673569 | Completed Phase 2

• 3 other identifiers: JHOC-J0655, CDR0000512886P30CA006973JHOC-J0655
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how well patients will respond to treatment. PURPOSE: This phase II trial is studying how well a laboratory test predicts response to erlotinib in patients with metastatic or unresectable non-small cell lung cancer that did not respond to previous treatment.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (3)

• Quantitative assessment of phospho-ERK

• Extent of inhibition of ERK phosphorylation by erlotinib hydrochloride

• Clinical response

Secondary Outcomes (5)

• Extent of inhibition of epidermal growth factor receptor (EGFR) and AKT phosphorylation by erlotinib hydrochloride

• Toxicity

• Frequency and proportion of patients with complete response, partial response, stable disease, and progressive disease

• Comparison of ex vivo and in vivo effects of erlotinib hydrochloride

• Proportion of patients with EGFR gene amplification and gene mutation with an ex vivo response and clinical response

Interventions

erlotinib hydrochloride DRUG

gene expression analysis GENETIC

protein expression analysis GENETIC

immunoenzyme technique OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

needle biopsy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or unresectable non-small cell lung cancer * Relapsed disease * Failed ≥ 1 prior chemotherapy regimen * Measurable disease * Tumor must be accessible to fine-needle aspiration * No uncontrolled brain metastases * Patients with brain metastases must have stable neurologic status after local therapy (surgery or radiotherapy) for ≥ 4 weeks and no neurologic dysfunction that would preclude evaluation of neurologic and other adverse events PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \> 12 weeks * WBC \> 3,000/mm³ * Absolute neutrophil count \> 1,500/mm³ * Platelet count \> 100,000/mm³ * Bilirubin normal * PT and activated PTT normal * Creatinine normal OR creatinine clearance \> 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled intercurrent illness, including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would preclude study compliance * No significant ophthalmologic abnormalities\*, including any of the following: * Severe dry eye syndrome * Keratoconjunctivitis sicca * Sjögren's syndrome * Severe exposure keratopathy * Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) * No serious, nonhealing wound, ulcer, or bone fracture * No significant traumatic injury within the past 14 days NOTE: \*Patients with mild forms of any of the above ophthalmologic abnormalities, an asymptomatic history, or a normal ophthalmologic examination allowed at the discretion of the investigator. Patients with treatable conditions (e.g., infectious keratitis/conjunctivitis or allergic conjunctivitis) allowed after treatment or resolution of the condition. PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior small molecule inhibitors of epidermal growth factor receptor, including erlotinib hydrochloride or gefitinib * At least 4 weeks since prior anticancer therapy, including chemotherapy, radiotherapy, biologic therapy, or other investigational therapy (6 weeks for nitrosoureas or mitomycin C) * More than 14 days since prior major surgery or open biopsy and recovered * At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following: * Itraconazole * Herbal extracts and tinctures, including any of the following: * Hydrastis canadensis (goldenseal) * Uncaria tomentosa (cat's claw) * Echinacea angustifolia roots * Trifolium pratense (wild cherry) * Chamomile * Licorice root * Dillapiol * Naringenin * No concurrent inducers of CYP3A4, including any of the following: * Phenytoin * Carbamazepine * Rifampin * Barbiturates * Hypericum perforatum (St. John's wort) * No concurrent chemotherapy * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent radiotherapy, including palliative radiotherapy * No concurrent therapeutic anticoagulation * No other concurrent anticancer agents or therapies

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Gene Expression Profiling; Immunoenzyme Techniques; Immunologic Techniques; Biopsy, Needle

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Genetic Techniques; Investigative Techniques; Immunoassay; Immunohistochemistry; Molecular Probe Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures

Study Officials

• Charles M. Rudin, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: September 1, 2006
• Primary Completion: July 1, 2007
• Last Updated: August 9, 2010

Record last verified: 2010-08

Locations

US (1)