Clinical trial · Interventional
Irinotecan, Capecitabine and Avastin for Metastatic Colorectal Cancer as Salvage Treatment
A Phase II Study of Irinotecan, Capecitabine and Avastin in Patients With Metastatic Colorectal Cancer, Who Have Progressed After 1ST Line Therapy With Folfox/Avastin.
NCT00717990CI-TRIAL-00019370terminatedPhase 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): Poor Accrual
Summary
Brief summary (as posted)
This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- XELIRI/Avastin
- interventionNames
- Drug: Capecitabine
- Drug: Bevacizumab
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- up to 6 months
Secondary outcomes (5)
- measure
- Time To Progression
- timeFrame
- 1 year
- measure
- Toxicity profile
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 * 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 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 metastasis * 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.