NCT00353457

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

Phase II Study of Capecitabine, Oxaliplatin and Cetuximab Given Throughout Multi-Modal Therapy for Locally Advanced Rectal Adenocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study of induction chemotherapy (capecitabine, oxaliplatin and cetuximab (erbitux)) followed by capecitabine, oxaliplatin, cetuximab and radiotherapy followed by surgery followed by adjuvant capecitabine, oxaliplatin and cetuximab for locally advanced resectable rectal cancer.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2006-07-18
• Last updated: 2020-04-09