Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC

PHASE3CompletedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

April 30, 2013

Study Completion Date

November 30, 2013

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Docetaxel

"GD Group: 40 mg/m\^2 on days 1 and 8, every 21 days~DCb Group: 75 mg/m\^2 on day 1~DV Group: 50 mg/m\^2 on days 1 and 15, every 28 days"

DRUG

Vinorelbine

DV Group: 35 mg/m\^2 on days 1 and 15

DRUG

Carboplatin

"GCb Group: Area under the curve (AUC) 5 on day 1, every 21 days~DCb Group: AUC 6 on day 1, every 21 days~Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed."

DRUG

Gemcitabine

"GCb Group: 1,250 mg/m\^2 on days 1 and 8~GD Group: 1,250 mg/m\^2 on days 1 and 8~Control Arm: Patients received up to 6 cycles, and no maintenance therapy was allowed."

Trial Locations (9)

21231

Johns Hopkins Sidney Kimmell Comprehensive Cancer Center, Baltimore

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

33805

Center for Cancer Care & Research/Watson, Lakeland

34748

Leesburg Regional Medical Center, Leesburg

48201

Barbara Ann Karmanos Cancer Institute, Detroit

74245

Klinik Loewenstein, Löwenstein

68510-2496

Southeast Nebraska Cancer Center, Lincoln

19111-2947

Fox Chase Cancer Center, Philadelphia

00716

Ponce School of Medicine, Ponce

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER