Capecitabine,Oxaliplatin & Erbitux Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

June 30, 2011

Study Completion Date

June 30, 2011

Conditions
Rectal Cancer
Interventions
DRUG

Capecitabine, Oxaliplatin and Cetuximab

Capecitabine 825mg/m2 po BID D1-15 of 21 x2 cycles (Cyle 1 and 2), Capecitabine 825mg/m2 po BID weekly Sun PM-Fri AM x2 cycles (cycle 3 and 4), Capecitabine 825mg/m2 po BID D1-15 of 21 x4 cycles (cycle 5,6,7,8) Oxaliplatin 130mg/m2 IV Day 1 every 3 weeks x2 cycles (Cycle 1 and 2), Oxaliplatin 50mg/m2 IV weekly every Monday x2 cycles (Cycle 3 and 4), Oxaliplatin 130mg/m2 IV day 1 every 3 weeks x4 cycles (Cycles 5,6,7,8) Cetuximab 400mg/m2 IV cycle 1 day1, Cetuximab 250mg/m2 Day 1,8,15 of 21 for cycles 1-8

RADIATION

Radiation

45 Gy in 25 fractions, 3-fraction boost 5.4 Gy

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Roche Pharma AG

INDUSTRY

lead

Abramson Cancer Center at Penn Medicine

OTHER