Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

November 30, 2004

Primary Completion Date

June 30, 2010

Study Completion Date

December 31, 2010

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Docetaxel, Cisplatin and STI571

"Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given.~Phase 1 dose levels are:~* Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg~* Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg~* Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg~* Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg~* Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg~* Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg~Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II."

DRUG

Docetaxel

DRUG

Cisplatin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT02127372 - Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571 | Biotech Hunter | Biotech Hunter