Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

February 29, 2008

Study Completion Date

January 31, 2009

Conditions
Esophagus Cancer
Interventions
DRUG

Oxaliplatin

40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts

DRUG

Docetaxel

20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts

DRUG

Capecitabine

In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.

RADIATION

Radiation therapy

In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).

Trial Locations (7)

30060

Wellstar Cancer Research, Marietta

30342

Atlanta Cancer Care, Atlanta

30501

Northeast Georgia Medical Center, Gainesville

32256

Integrated Community Oncology Network, Jacksonville

37203

Tennessee Oncology, Nashville

40207

Consultants in Blood Disorders and Cancer, Louisville

90211

Tower Oncology, Beverly Hills

All Listed Sponsors
collaborator

Sanofi-Synthelabo

INDUSTRY

collaborator

Aventis Pharmaceuticals

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER