Clinical trial · Interventional
Lohp, 5-Fu/Lv and Bevacizumab, Alternative With Cpt-11, 5-Fu/Lv and Cetuximab In Metastatic Crc
Phase II Study Of Weekly Administration Oxaliplatin Plus 5-Fu/Lv (Aio Regimen) Plus Bevacizumab, Alternative With Irinotecan Plus 5-Fu/Lv(Aio Regimen) Plus Cetuximab, As Salvage Treatment In Pretreated Patients With Mcrc
NCT00755118CI-TRIAL-00019380terminatedPhase 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)
The aim of this study is to evaluate the efficacy of the effective drugs in a alternating chemotherapy schedules in pretreated patients with mCRC, who have received all effective drugs.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- LoHP/AIO/Avastin-\>CPT-11/AIO/Erbitux
- interventionNames
- Drug: Oxaliplatin
- Drug: 5-Fluorouracil
- Drug: Leucovorin
- Drug: Bevacizumab
- Drug: Irinotecan
- Drug: Cetuximab
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 3 - 6 month
Secondary outcomes (5)
- measure
- Time To Progression
- timeFrame
- 1 year
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 progress after 1st line therapy with FOLFOX/AVASTIN * 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 * Previous treatments with all effective drugs for metastatic colorectal cancer (CPT-11, LOHP, 5-FU/XELODA, Erbitux, Avastin) Exclusion Criteria: * History of serious cardiac disease (unstable angina, congestive heart failure,uncontrolled cardiac arrhythmias) * History of myocardial infarction or stroke within 6 months * Clinically significant peripheral vascular disease * History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0 * Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1 * Presence of central nervous system or brain metastases * Evidence of bleeding diathesis or coagulopathy * Blood pressure \> 150/100 mmHg * Pregnant or lactating woman * Life expectancy \< 3 months * Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow * Metastatic infiltration of the liver \>50% * Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy * Active infection requiring antibiotics on Day 1 * 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.