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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

Phase 2
70 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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



- 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


- 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.

Inclusion Criteria


- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage IIIB or IV disease

- Measurable disease by RECIST criteria

- Treated brain metastases allowed provided patient is asymptomatic


- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 8.0 g/dL

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 4 times ULN

- Creatinine ≤ 1.5 times ULN

- Bilirubin normal

- No history of severe hypersensitivity to gemcitabine hydrochloride

- No severe comorbid illness

- Able to participate in quality of life assessments


- Recovered from prior oncologic or other major surgery

- One prior treatment for NSCLC allowed provided it was in the neoadjuvant or adjuvant

- At least 1 year since prior treatment in the neoadjuvant or adjuvant setting

- No other concurrent antineoplastic or antitumor agents or therapies, including
chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy

- No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant

Outcome Time Frame:

Six months

Safety Issue:


Principal Investigator

Thomas E Stinchcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

LCCC 0512



Start Date:

March 2006

Completion Date:

March 2014

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
Batte Cancer Center at Northeast Medical Center Concord, North Carolina  28025
Evanston Hospital Evanston, Illinois  60201-1781
Highlands Oncology Group - Fayetteville Fayetteville, Arkansas  72703
Rex Cancer Center at Rex Hospital Raleigh, North Carolina  27607
University of Tennessee Cancer Institute - Memphis Memphis, Tennessee  38104
Cape Fear Valley Medical Center Cancer Center Fayetteville, North Carolina  28302-2000
Summit Cancer Care Savannah, Georgia  31405
Kingsport Hematology-Oncology Associates Kingsport, Tennessee  37660