Amrubicin + Cyclophosphamide in Advanced Solid Organ Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Lung Cancer
Interventions
DRUG

Amrubicin

"* Dose Level -1: 20mg/m2~* Dose Level 1: 25mg/m2~* Dose Level 2: 30mg/m2~* Dose Level 3: 35mg/m2~* Dose Level 4: 40mg/m2~Amrubicin will be given as a slow IV push or infusion over approximately 5 minutes once daily for 3 consecutive days starting on day 1 of each 21 day cycle."

DRUG

Cyclophosphamide

Cyclophosphamide will be given at a fixed dose as 500mg/m2 IV infusion over 30-60 minutes on day 1 of each 21 day cycle (following amrubicin).

Trial Locations (10)

19046

Fox Chase Cancer Center Extramural Research Program, Rockledge

19713

Helen F. Graham Cancer Center, Newark

46202

Indiana University Simon Cancer Center, Indianapolis

46601

Northern Indiana Cancer Research Consortium, South Bend

47303

Medical Consultants, P.C., Muncie

47403

Cancer Care Center of Southern Indiana, Bloomington

61401

Medical & Surgical Specialists, LLC, Galesburg

63110

Siteman Cancer Center, St Louis

72764

Highlands Oncology Group, Springdale

97213

Providence Portland Medical Center, Portland

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

collaborator

Hoosier Cancer Research Network

OTHER

lead

Lawrence Einhorn

OTHER