Metastatic Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Cetuximab, FOLFOXIRI
Brief summary
This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.
Detailed description
The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab
Interventions
DRUGIrinotecan
Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1
DRUGLeukovorin
Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3
DRUGOxaliplatin
Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV
DRUG5-FLUOROURACIL
5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3
DRUGCetuximab
Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy
Sponsors
University Hospital of Crete
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically proven metastatic adenocarcinoma of the colon or rectum * Previous chemotherapy for metastatic disease not allowed. Patients who received prior adjuvant 5-FU-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy * Patients with operable metastatic disease are excluded from the study * Age 18-70 years * Performance status (ECOG) 0-1 * At least one bidimensionally measurable lesion of \>= 2cm * Life expectancy of at least 6 months * Adequate hematologic parameters (absolute neutrophil count \>= 1.5x109/L and platelets \>=100x109/L) * Creatinine and total bilirubin \< 1.25 times the upper limit of normal * Aspartate and alanine aminotransferase \< 3.0 times the upper limit of normal (\<5 times in case of liver mets)
Exclusion criteria
* Absence of active infection or malnutrition (loss of more than 20% of the body weight) * No history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated * Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields. * Patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded. * All patients will have to sign written informed consent in order to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to Tumor Progression | 1 year |
| Overall Survival | 1 year |
| Resectability rates | Resectability at the end of treatment (4 or 6 months from the entry to the study) |
| Pharmacogenomic analysis | During the treatment |
| Q-Twist analysis of Quality of life | Quality of life assessment every 8 weeks |
| Toxicity profile | Toxicity assessment on each chemotherapy cycles (every 15 days) |
Countries
Greece
Outcome results
None listed