Clinical trial NCT00550537
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
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2007-10-01; Completion date: 2013-12-01
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Detailed description:
OBJECTIVES:

Primary

* To define a pre-treatment tumor proteomic profile that predicts response, stable disease, or progressive disease in patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer treated with erlotinib hydrochloride.

Secondary

* To test and refine a pre-treatment serum proteomic expression pattern that predicts response to erlotinib hydrochloride and/or carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride.
* To test and refine tumor proteomic profiles that predict response to carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride.
* To analyze individual and pattern(s) of erlotinib hydrochloride-induced genomic and proteomic biomarker changes in relation to response or non-response to treatment.
* To correlate the efficacy and toxicity of erlotinib hydrochloride with expression of EGFR, EGFR pathway, ErbB family, and other related biomarkers.
* To determine 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.
* To estimate response rate and progression-free and overall survival of patients treated with erlotinib hydrochloride as initial therapy.
* To characterize the safety profile of erlotinib hydrochloride in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily until disease progression.

At the time of disease progression, patients receive standard chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Patients with non-squamous cell non-small cell lung cancer also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses.

Tumor tissue, plasma, serum, and urine samples are collected at baseline for proteomics analysis.

After the completion of study treatment, patients are followed every 8 weeks.

Arms: arm 1: Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
Interventions: intervention 1: bevacizumab intervention 2: carboplatin intervention 3: erlotinib hydrochloride intervention 4: paclitaxel intervention 5: gene expression analysis intervention 6: protein expression analysis intervention 7: proteomic profiling intervention 8: laboratory biomarker analysis
Intervention descriptions: intervention 1: 15 mg/m2 given through a vein for every 3 weeks intervention 2: AUC = 6 given through a vein on day 1 of each cycle. intervention 3: 150 mg taken by mouth daily intervention 4: 200 mg/m2 given through a vein on day 1 of each cycle. intervention 5: Blood and tissue collection. intervention 6: Blood and tissue collection. intervention 7: Blood and tissue collection. intervention 8: Blood and tissue collection.

Protocol documents: