Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

NCT00550537 | Completed Phase 2 Results DMC

• 4 other identifiers: VICC-THO-0640P30CA068485VU-VICC-THO-0640VU-VICC-070494
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Studying samples of tumor tissue, blood, and urine in the laboratory from patients receiving erlotinib may help doctors predict how patients will respond to treatment. PURPOSE: The phase II trial is studying proteomic profiling to see how well it predicts response in patients receiving erlotinib for stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; adenocarcinoma of the lung

Outcome Measures

Primary Outcomes (1)

• Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease

  End of treatment date

Secondary Outcomes (9)

• Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride

  End of treatment date

• Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride

  End of treatment date

• Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment

  End of treatment date

• Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers

  End of treatment date

• Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy

  End of treatment date

Study Arms (1)

Treatment

EXPERIMENTAL

Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.

Drug: bevacizumab; Drug: carboplatin; Drug: erlotinib hydrochloride; Drug: paclitaxel; Genetic: gene expression analysis; Genetic: protein expression analysis; Genetic: proteomic profiling; Other: laboratory biomarker analysis

Interventions

bevacizumab DRUG

15 mg/m2 given through a vein for every 3 weeks

Treatment

carboplatin DRUG

AUC = 6 given through a vein on day 1 of each cycle.

Treatment

erlotinib hydrochloride DRUG

150 mg taken by mouth daily

Treatment

paclitaxel DRUG

200 mg/m2 given through a vein on day 1 of each cycle.

Treatment

gene expression analysis GENETIC

Blood and tissue collection.

Treatment

protein expression analysis GENETIC

Blood and tissue collection.

Treatment

proteomic profiling GENETIC

Blood and tissue collection.

Treatment

laboratory biomarker analysis OTHER

Blood and tissue collection.

Treatment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following criteria: * Stage IIIB (with pleural effusion) or stage IV disease * Recurrent disease after prior surgery * Measurable or evaluable disease is desirable but not required * No untreated symptomatic brain metastases * Patients who are neurologically unstable despite radiotherapy for the brain metastases are not eligible * No requirement for steroids to control neurological symptoms PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,500/mm³ * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 1.5 mg/dL * Normal hemostasis by history * PT/PTT within 0.5 seconds of normal range * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to undergo biopsy procedures * No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients of this product * No other concurrent malignancies or malignancies diagnosed within the past 5 years, except basal cell carcinoma or cervical cancer in situ * No significant cardiac disease, including any of the following: * NYHA class III or IV heart disease * Uncontrolled dysrhythmia * Myocardial infarction within the past 6 months * No evidence of clinically active interstitial lung disease * Chronic stable radiographic changes that are asymptomatic allowed * No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial * No uncontrolled hypertension * Blood pressure must be ≤ 150/90 mmHg on a stable antihypertensive regimen PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 months since prior adjuvant chemotherapy * No unresolved chronic toxicity \> CTC grade 2 from prior anticancer therapy (except alopecia) * More than 30 days since prior non-approved or investigational drugs * No prior chemotherapy for advanced NSCLC * No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or St. John's wort * No concurrent administration of other drugs known to inhibit EGFR * No other concurrent anti-neoplastic or anti-tumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy * No other concurrent investigational agents * Concurrent cardioprotective doses of aspirin, as recommended by the physician, for cardiovascular disease allowed

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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar; Adenocarcinoma of Lung

Interventions

Bevacizumab; Carboplatin; Erlotinib Hydrochloride; Paclitaxel; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Genetic Techniques; Investigative Techniques

Results Point of Contact

• Title: Dr. Leora Horn, Principal Investigator
• Organization: Vanderbilt-Ingram Cancer Center

leora.horn@vanderbilt.edu

Study Officials

• David Carbone, M.D., Ph.D.

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 26, 2007
• First Posted: October 30, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2013
• Last Updated: June 8, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-05

Locations

US (7)