Conditions: Colorectal Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 94
Healthy volunteers: no

Brief summary:
This Phase II study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. Patients must not have received anti-EGFR (Epidermal Growth Factor Receptor) treatment (for example, cetuximab, panitumumab) in the past. Patients with wild-type KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either BIBW 2992 or cetuximab. Patients with KRAS mutated colorectal cancer will not be randomised, but will all receive BIBW 2992. The main objectives of the study are: to compare the effectiveness of BIBW 2992 with that of cetuximab in patients with KRAS wild type cancer, and to assess the effectiveness of BIBW 2992 in patients with KRAS mutated cancer.

Detailed description:

Arms:
arm 1: Patients receive BIBW 2992 tablets once daily arm 2: Patients receive cetuximab intravenously once a week, every week

Interventions: intervention 1: BIBW 2992 intervention 2: Cetuximab
Intervention descriptions: intervention 1: Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management intervention 2: Patients receive cetuximab intravenously, once a week, every week

Protocol document: