Multicentre, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With Oxaliplatin and Capecitabine (XELOX) for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.
- This open-label, non-controlled, multicentre, phase II study will recruit 53 elderly
patients with diagnosis of metastatic colorectal cancer.
- All patients will receive 4 cycles of treatment with cetuximab plus XELOX followed by
cetuximab plus capecitabine as maintenance therapy until progression of disease,
occurrence of unacceptable toxicity to the study drugs, or withdrawal of consent by the
patient.
- The planned duration of a cycle is 3 weeks.
- Cetuximab therapy will not be delayed for chemotherapy-related toxicity and vice versa.
If patients benefit from combination therapy, but develop unacceptable intolerance to
oxaliplatin and/or capecitabine, cetuximab may be continued in combination with the
other chemotherapy drug and/or as a single agent. In case of cetuximab intolerance,
patients should continue with chemotherapy treatment until progression disease.
- Evaluations:
- Efficacy data (response rate, progression-free survival, duration of response and
survival) and safety data will be collected. The investigators will assess
responses to treatment.
- When the treatment is stopped either because of disease progression or occurrence
of unacceptable toxicity, the patients will enter a follow-up period where the
progression-free survival, the subsequent lines of treatment and the survival data
will be collected every 12 weeks.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed objective response rate
2007-2009
No
Javier Sastre
Study Chair
H. Clinico San Carlos. Madrid. Spain
Spain: Spanish Agency of Medicines
TTD-06-05
NCT00531115
November 2007
April 2009
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