Study of Low Dose Chemotherapy Plus Sorafenib as Initial Therapy for Patients With Advanced Non-Squamous Cell NSCLC

PHASE2TerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

March 31, 2011

Conditions
Non Squamous Cell Lung CancerNon Small Cell Lung Cancer
Interventions
DRUG

Docetaxel + Sorafenib

Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated after every 8 weeks. Treatment with metronomic chemotherapy and sorafenib will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with sorafenib will then continue until disease progression, intolerable toxicity or withdrawal of consent.

Trial Locations (1)

35294 - 0104

University of Alabama at Birmingham, Birmingham

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

collaborator

Bayer

INDUSTRY

lead

Francisco Robert,MD

OTHER