Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Summary

This phase II trial is studying how well docetaxel given together with cisplatin and pegfilgrastim followed by erlotinib hydrochloride works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving dose-dense combination chemotherapy together with pegfilgrastim and erlotinib hydrochloride may kill more tumor cells

Conditions

• Adenocarcinoma of the Lung
• Adenosquamous Cell Lung Cancer
• Bronchoalveolar Cell Lung Cancer
• Large Cell Lung Cancer
• Non-small Cell Lung Cancer
• Recurrent Non-small Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

DRUG

cisplatin

Given IV

BIOLOGICAL

pegfilgrastim

Given SC

DRUG

erlotinib hydrochloride

Given PO

OTHER

laboratory biomarker analysis

Optional correlative study

GENETIC

polymorphism analysis

Correlative study

OTHER

pharmacogenomic studies

Correlative study

GENETIC

genetic linkage analysis

Correlative study

DRUG

docetaxel

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• OSI Pharmaceuticals

  collaborator INDUSTRY

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• William Petty · Wake Forest University Health Sciences

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2011-02-28

Completion

2011-02-28

FDA Drug

Yes

Countries

• United States

Study Locations