Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

December 31, 2006

Study Completion Date

December 31, 2006

Conditions
Non-Small-Cell Lung Carcinoma
Interventions
DRUG

Cetuximab + platinum + gemcitabine

Solution, IV, Cetuximab: 400mg/m2 on Day 1 then given weekly at 250mg/m2 starting on Day 8 + Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks. Cetuximab is given weekly, Maximum of 6 cycles (18 weeks) Cetuximab will be continued during the period following discontinuation of chemotherapy, until disease progression or cetuximab intolerance.

DRUG

Platinum + Gemcitabine

Solution, IV, Gemcitabine given at 1250mg/m2 (Day 1 \& Day 8 of each cycle) + Cisplatin given at 75mg/m2 or Carboplatin AUC=5, Cycle of therapy is every 3 weeks, Maximum of 6 cycles = 18 weeks.

Trial Locations (38)

Unknown

Local Institution, Mobile

Local Institution, Anchorage

Local Institution, Bakersfield

Local Institution, Corona

Local Institution, Oxnard

Local Institution, San Diego

Local Institution, Whittier

Local Institution, Lakewood

Local Institution, Boynton Beach

Local Institution, Brooksville

Local Institution, Inverness

Local Institution, Pembroke Pines

Local Institution, Austell

Local Institution, Honolulu

Local Institution, Skokie

Local Institution, Muncie

Local Institution, Annapolis

Local Institution, Frederick

Local Institution, Rockville

Local Institution, Plymouth

Local Institution, Farmington

Local Institution, Armonk

Local Institution, Stony Brook

Local Institution, Gastonia

Local Institution, Wilmington

Local Institution, Bismarck

Local Institution, Cincinnati

Local Institution, Portland

Local Institution, Charleston

Local Institution, Dallas

Local Institution, Vancouver

Local Institution, Edmonton

Local Institution, Moncton

Local Institution, Hamilton

Local Institution, Montreal

Local Institution, Toronto

Local Institution, Windsor

Local Institution, Greenfield Park

All Listed Sponsors
lead

Eli Lilly and Company

INDUSTRY

NCT00112346 - Study of Gemcitabine/Platinum +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter