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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00550537
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    15 mg/m2 given through a vein for every 3 weeks
  • carboplatin — DRUG
    AUC = 6 given through a vein on day 1 of each cycle.
  • erlotinib hydrochloride — DRUG
    150 mg taken by mouth daily
  • paclitaxel — DRUG
    200 mg/m2 given through a vein on day 1 of each cycle.
  • gene expression analysis — GENETIC
    Blood and tissue collection.
  • protein expression analysis — GENETIC
    Blood and tissue collection.
  • proteomic profiling — GENETIC
    Blood and tissue collection.
  • laboratory biomarker analysis — OTHER
    Blood and tissue collection.

Study Details

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.

Key Dates

First listed
Oct 30, 2007
Start date
Oct 31, 2007
Status verified
May 2017
Primary completion
Sep 30, 2011
Completion
Dec 31, 2013

Study Design

Enrollment
116 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease [ Time Frame: End of treatment date ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Florida Shands Cancer CenterGainesvilleFlorida32610-0232-
Emory UniversityAtlantaGeorgia30308-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-0942-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-
Vanderbilt-Ingram Cancer Center - Cool SpringsNashvilleTennessee37064-
Vanderbilt-Ingram Cancer Center at FranklinNashvilleTennessee37064-
M. D. Anderson Cancer Center at University of TexasHoustonTexas77030-4009-

Find similar trials in Gainesville, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Florida Shands Cancer Center· Gainesville, FLEmory University· Atlanta, GAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIVanderbilt-Ingram Cancer Center· Nashville, TNVanderbilt-Ingram Cancer Center - Cool Springs· Nashville, TNVanderbilt-Ingram Cancer Center at Franklin· Nashville, TN

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