NCT00531115

Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With XELOX for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-line Treatment in Elderly Patients With Metastatic Colorectal Cancer.

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab plus capecitabine as first line treatment in elderly patients with metastatic colorectal cancer

Detailed description

* 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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	cetuximab 5mg/ml	Weekly administration of Cetuximab (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes) Oxaliplatin. 130 mg/m2 every three weeks. on day 1 for 4 cycles Capecitabine. 1000 mg/m2 twice daily (2.000 mg/m2 total daily dose) or 750 mg/m2 if Cl Cr=30-50 ml/min (1500 mg/m2 total daily dose) for two weeks (on days 1 to 14) followed by one week of rest (on days 15 to 21). The patients will receive 4 cycles of cetuximab plus combination chemotherapy administered every 3 weeks in order to achieve a noticeable response. Then, oxaliplatin treatment will be stopped after a maximum of 4 infusions to prevent appearance of neuropathy and then followed by capecitabine 2 weeks out of 3, and cetuximab weekly as maintenance treatment.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2007-09-18
• Last updated: 2013-02-20

Locations

1 site across 1 country: Spain