Gemcitabine and/or Erlotinib as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer



Status:Archived
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011

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Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer


RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. It is not yet known whether gemcitabine and erlotinib are more effective when given
alone or together in treating non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how
well they work when given alone or together as first-line therapy in treating older patients
with stage IIIB or stage IV non-small cell lung cancer.


OBJECTIVES:

Primary

- Compare the progression-free survival rate of older patients with stage IIIB or IV
non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib
hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line
therapy.

Secondary

- Determine the response rate in patients receiving these regimens.

- Determine the overall survival rate in patients receiving these regimens.

- Determine the toxicity profile of these regimens in these patients.

- Determine the quality of life of patients receiving these regimens.

OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study.
Patients are stratified by gender, smoking status (never or light vs current or former), and
ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with
progressive disease may cross over to arm II.

- Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21.

- Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib
hydrochloride as in arm II.

In all arms, treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2 months for 3 years.


We found this trial at
11
sites
101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Raleigh, North Carolina 27607
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Concord, North Carolina 28025
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Evanston, Illinois 60201
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Fayetteville, Arkansas 72703
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Fayetteville, North Carolina 28302
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Hackensack, New Jersey 07601
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Kingsport, Tennessee 37660
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Memphis, Tennessee 38104
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Savannah, Georgia 31405
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