Clinical trial · Interventional
A Phase I/II Study of IXO With Bevacizumab in Patients With Metastatic Colorectal Cancer
A Phase I/II Clinical Trial of Combination of Irinotecan, Xeloda and Oxaliplatin (IXO) Regimen With Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer
- 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)
Triplets of irinotecan, oxaliplatin and infusional 5-fluorouracil(FU)/leucovorin (LV) are associated with high response rates and long survival as first-line treatment for metastatic colorectal cancer (mCRC). The oral fluoropyrimidine, capecitabine, is better tolerated and shows better response rates than 5-FU/LV in metastatic colorectal cancer. A phase I dose-escalation study established dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II doses (RPIID) of irinotecan, oxaliplatin and capecitabine. This phase I /II study is to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), phase II recommended dose (RD) of IXO and bevacizumab combination and safety at the RD in an expanded cohort.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IXO regimen + bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IXO regimen + bevacizumab
- description
- This is phase I/II safety and efficacy study. There is only one arm of Irinotecan, Xeloda and Oxaliplatin (IXO) regimen with Avastin (bevacizumab)
- interventionNames
- Drug: IXO regimen + bevacizumab
Primary outcomes (2)
- measure
- Phase I: Assess the MTD and RD for phase II of IXO and bevacizumab combination given every 3 weeks in 1st line patients with mCRC
- timeFrame
- 3-week cycle, continuous monitoring of AE
- measure
- Phase II: Using the RD established in phase I, assess efficacy of the IXO with bevacizumab combination as measured by progression-free survival
- timeFrame
- 3-week cycle, continuous monitoring of AE
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented adenocarcinoma of the colon or rectum. * Advanced and/or metastatic disease, incurable with standard therapy. * Unresectable advanced and/or metastatic unidimensionally measurable disease (RECIST scale). * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Age: over 18 years. * Adequate haematological, renal and hepatic functions * Patient consent must be obtained according to local REB requirements. * Patients must be accessible for treatment and follow up. Exclusion Criteria: * Previous or concurrent malignancies * Pregnant or lactating women. Women of childbearing potential must have had a negative pregnancy test within 7 days prior to registration. * Concurrent treatment with other experimental drugs or anticancer therapy. * Previous chemotherapy for advanced and/or metastatic disease. * Previous adjuvant therapy with irinotecan or oxaliplatin. * Previous full dose curative pelvic radiation therapy. * Patients with documented brain metastases. * Serious illness or medical condition. * Gilbert's disease * Use of enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine
References
Publications (0)
Data not yet available