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.
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Confirmed objective response rate [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
- Disease control, Time to progression, progression-free survival,Time to treatment failure,Determine time to onset of response, Duration of response, Overall survival, To determine biologic prognostic factors [ Time Frame: 2007-2009 ] [ Designated as safety issue: No ]
- Treatment safety [ Time Frame: 2007-2009 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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.
- 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.
- 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.
|Spanish Cooperative Group for Gastrointestinal Tumour Therapy|
|Madrid, Spain, 28046|
|Study Chair:||Javier Sastre||H. Clinico San Carlos. Madrid. Spain|