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.
Overview
- Phase
- Phase 2
- Intervention
- cetuximab 5mg/ml
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Confirmed objective response rate
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent before any study related activities are carried out
- •Men and women \>= 70 years.
- •Histologically confirmed diagnosis of CRC.
- •Non-resectable and/or non-operable metastatic colorectal carcinoma.
- •Presence of at least one lesion by two-dimensional measurement; index lesions should not be in a region with previous irradiation.
- •Availability of tumor tissue for immunohistochemical analysis
- •Karnofsky functional status \>= 80% at the time of enrollment in the study.
- •Life expectancy greater than 3 months.
- •Patients will not have received chemotherapy for advanced or metastatic disease. Patients with the following characteristics will be included:
- •Recurrence after neoadjuvant and/or adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free interval \> 12 months following conclusion of treatment.
Exclusion Criteria
- •Documented or suspected cerebral and/or leptomeningeal metastases.
- •Surgery (excluding biopsy for diagnosis) and/or radiotherapy during the 4 weeks prior to inclusion in the study.
- •Chronic, concomitant systemic immunotherapy, chemotherapy, or hormonal treatment for cancer.
- •Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
- •Participation in another clinical trial with medication in the past 30 days
- •Prior participation in a study in which treatment with cetuximab may be assigned (whether or not treatment with cetuximab is received).
- •Prior malignant tumor in the past 5 years, except for history of adequately treated basal cell skin cancer or pre-invasive cervical cancer .
- •Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome or history of inflammatory intestinal disease, acute or subacute intestinal occlusion or other disease which could alter drug absorption.
- •Evidence of grade 3 or 4 allergic reaction to any treatment components or other fluoropyrimidines.
- •Clinically relevant peripheral neuropathy.
Arms & Interventions
1
Intervention: cetuximab 5mg/ml
Outcomes
Primary Outcomes
Confirmed objective response rate
Time Frame: 2007-2009
Secondary Outcomes
- 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(2007-2009)
- Treatment safety(2007-2009)