Clinical trial · Interventional
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer
A Triplet Combination With Irinotecan Plus Oxaliplatin,Continuous Infusion 5-Fluorouracil And Leucovorin Plus Cetuximab As First Line Treatment In Metastatic Colorectal Cancer. A Pilot Phase II Trial
NCT00689624CI-TRIAL-00019216completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FLUOROURACIL | Drug | Fluorouracil | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leukovorin | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- FOLFOXIRI+Erbitux
- interventionNames
- Drug: Irinotecan
- Drug: Leukovorin
- Drug: Oxaliplatin
- Drug: 5-FLUOROURACIL
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 2 months
Secondary outcomes (6)
- measure
- Resectability rates
- timeFrame
- Resectability at the end of treatment (4 or 6 months from the entry to the study)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.