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This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FOLFOXIRI+Erbitux |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Resectability rates | Resectability at the end of treatment (4 or 6 months from the entry to the study) | |
| Time to Tumor Progression | 1 year | |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Souglakos, MD | University Hospital of Crete | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Crete | Heraklion | Greece |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D005472 | Fluorouracil |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
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| Leukovorin | Drug | Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3 |
|
|
| Oxaliplatin | Drug | Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV |
|
|
| 5-FLUOROURACIL | Drug | 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 |
|
|
| Cetuximab | Drug | Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy |
|
|
| 1 year |
| Toxicity profile | Toxicity assessment on each chemotherapy cycles (every 15 days) |
| Pharmacogenomic analysis | During the treatment |
| Q-Twist analysis of Quality of life | Quality of life assessment every 8 weeks |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013763 |
| Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |