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

NCT00550537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2017-06-08

Study results available
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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

Interventions

DRUG

bevacizumab

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

DRUG

carboplatin

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

DRUG

erlotinib hydrochloride

150 mg taken by mouth daily

DRUG

paclitaxel

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

GENETIC

gene expression analysis

Blood and tissue collection.

GENETIC

protein expression analysis

Blood and tissue collection.

GENETIC

proteomic profiling

Blood and tissue collection.

OTHER

laboratory biomarker analysis

Blood and tissue collection.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • David Carbone, M.D., Ph.D. · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-09-30
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00550537 on ClinicalTrials.gov