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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT01557959
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cisplatin — DRUG
    Given IV
  • pegfilgrastim — BIOLOGICAL
    Given SC
  • erlotinib hydrochloride — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Optional correlative study
  • polymorphism analysis — GENETIC
    Correlative study
  • pharmacogenomic studies — OTHER
    Correlative study
  • genetic linkage analysis — GENETIC
    Correlative study
  • docetaxel — DRUG
    Given IV

Study Details

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

Key Dates

First listed
Mar 20, 2012
Start date
Jul 31, 2007
Status verified
May 2018
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

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

Arms

  • Experimental: Treatment (chemo, chemoprotection, antiangiogenesis therapy)
    Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Time to Progression [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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