Clinical trial · Interventional
Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC
A Parallel Phase II Study With Irinotecan/Cetuximab (Until PD) Followed by XELOX/Cetuximab (Until PD) vs the Reverse Sequence in Metastatic CRC With Previous Benefit on Irinotecan/Bevacizumab Based Therapy
NCT00755534CI-TRIAL-00009446terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to poor accrual
Summary
Brief summary (as posted)
This phase II study will evaluate which is the best way to administer cetuximab after recurrence in 1st line irinotecan+bevacizumab based treatment and to obtain results of the efficacy of the oxaliplatin+cetuximab combination as 2nd line treatment.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Irinotecan+Erbitux -\> XELOX+Erbitux
- interventionNames
- Drug: Irinotecan
- Drug: Capecitabine
- Drug: Cetuximab
- Drug: Oxaliplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- XELOX+Erbitux -\>Irinotecan+Erbitux
- interventionNames
- Drug: Irinotecan
- Drug: Capecitabine
- Drug: Cetuximab
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Time To Progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed locally advanced or metastatic colorectal cancer * Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) * ECOG performance status ≤ 2 * Age 18 - 72 years * Patients who have had a CR, PR or SD after 1st line therapy based on Irinotecan+Bevacizumab * Paraffin block from the primary tumor in order to perform tha mutational analysis of the KRAS gene * Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit),renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function * Patients must be able to understand the nature of this study * Written informed consent Exclusion Criteria: * Presence of central nervous system or brain metastases * Pregnant or lactating woman * Life expectancy \< 3 months * Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow or in the field where the treatment target is located * Peripheral neuropathy grade ≥2 * Known hypersensitivity to Erbitux * Metastatic infiltration of the liver \>50% * Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy * Active infection * Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer * Psychiatric illness or social situation that would preclude study compliance
References
Publications (0)
Data not yet available
No reference posted for this study.